<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714947</url>
  </required_header>
  <id_info>
    <org_study_id>C14014</org_study_id>
    <secondary_id>U1111-1187-6760</secondary_id>
    <nct_id>NCT01714947</nct_id>
  </id_info>
  <brief_title>Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib</brief_title>
  <official_title>Mass Balance, Pharmacokinetics, and Metabolism of [^14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Millennium Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total&#xD;
      radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in&#xD;
      plasma and urine, and of TRA in plasma and whole blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested&#xD;
      to treat participants who have advanced solid tumors or lymphomas. This study looked at mass&#xD;
      balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.&#xD;
&#xD;
      The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B.&#xD;
      Participants received:&#xD;
&#xD;
        -  [^14C]-alisertib 35 mg in Part A&#xD;
&#xD;
        -  alisertib 50 mg in Part B&#xD;
&#xD;
      Participants were asked to take a single dose of [^14C]-alisertib oral solution containing&#xD;
      80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally,&#xD;
      twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in&#xD;
      Part B.&#xD;
&#xD;
      This single center trial was conducted in United States. The overall time to participate in&#xD;
      this study was up to 117 days. Participants remained confined to clinic in Part A and made&#xD;
      multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose&#xD;
      of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a&#xD;
      final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up&#xD;
      assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2013</start_date>
  <completion_date type="Actual">June 14, 2013</completion_date>
  <primary_completion_date type="Actual">April 4, 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ae: Amount of [^14C]-Alisertib Excreted in Urine</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ae: Amount of [^14C]-Alisertib Excreted in Feces</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Total Radioactivity (TRA) in Urine and Feces</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fe: Fraction of Administered Dose of Alisertib Excreted in Urine</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ae: Amount of Alisertib Excretion in Urine</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance (CLR) of Alisertib</measure>
    <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (0 to 192 hours)</time_frame>
    <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (0 to 192 hours)</time_frame>
    <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution</measure>
    <time_frame>Predose and multiple timepoints post-dose (0 to 192 hours)</time_frame>
    <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events</measure>
    <time_frame>From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)</time_frame>
    <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs</measure>
    <time_frame>Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)</time_frame>
    <description>An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements</measure>
    <time_frame>Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)</time_frame>
    <description>Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Alisertib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1.&#xD;
Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[^14C]-alisertib</intervention_name>
    <description>[^14C]-alisertib oral solution</description>
    <arm_group_label>Alisertib</arm_group_label>
    <other_name>MLN8237</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alisertib</intervention_name>
    <description>Alisertib enteric coated tablets</description>
    <arm_group_label>Alisertib</arm_group_label>
    <other_name>MLN8237</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Each participants must meet all of the following inclusion criteria to be enrolled in the&#xD;
        study:&#xD;
&#xD;
          -  18 years or older.&#xD;
&#xD;
          -  Histologically or cytologically confirmed metastatic and/or advanced solid tumors or&#xD;
             lymphomas for which standard curative or life-prolonging treatment does not exist, or&#xD;
             is no longer effective or tolerable.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.&#xD;
&#xD;
          -  Expected survival longer than 3 months from enrollment in the study.&#xD;
&#xD;
          -  Radiographically or clinically evaluable tumor.&#xD;
&#xD;
          -  Suitable venous access for the conduct of blood sampling.&#xD;
&#xD;
          -  Recovered from the reversible effects of prior antineoplastic treatment (with the&#xD;
             exception of alopecia and Grade 1 neuropathy).&#xD;
&#xD;
          -  Female participants who are postmenopausal for at least 1 year OR are surgically&#xD;
             sterile OR if of childbearing potential, agree to practice 2 effective methods of&#xD;
             contraception at the same time.&#xD;
&#xD;
          -  Male participants who agree to practice effective barrier contraception during the&#xD;
             entire study and through 4 months after the last dose of study drug OR agree to&#xD;
             abstain from heterosexual intercourse.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants meeting any of the following exclusion criteria are not to be enrolled in the&#xD;
        study:&#xD;
&#xD;
          -  Female participants who are lactating or have a positive serum pregnancy test.&#xD;
&#xD;
          -  Treatment with any investigational products or systemic antineoplastic treatment&#xD;
             within 21 days before the first dose of alisertib.&#xD;
&#xD;
          -  Medical conditions requiring daily, chronic, or regular use of proton pump&#xD;
             inhibitors(PPIs) within 7 days preceding the first dose of alisertib, or H2-receptor&#xD;
             antagonists within 24 hours preceding the first dose of alisertib.&#xD;
&#xD;
          -  Participants requiring systemic anticoagulation (excluding low-dose aspirin, or&#xD;
             low-dose anticoagulation to maintain patency of venous access devices). Low molecular&#xD;
             weight heparin, administered as preventive treatment, is allowed if the participant&#xD;
             has tolerated treatment with a stable dose and schedule without bleeding complications&#xD;
             for more than 1 month.&#xD;
&#xD;
          -  Major surgery within the 14 days preceding the first dose of alisertib.&#xD;
&#xD;
          -  Infection requiring systemic intravenous (IV) antibiotic therapy within 14 days&#xD;
             preceding the first dose of study drug, or other severe infection.&#xD;
&#xD;
          -  Life-threatening or uncontrolled medical illness unrelated to cancer.&#xD;
&#xD;
          -  Ongoing nausea or vomiting that is Grade 2 or worse in intensity.&#xD;
&#xD;
          -  Diarrhea that is Grade 2 or worse in intensity or use of an antimotility agent to&#xD;
             control diarrhea to an intensity of Grade 1 or lower level.&#xD;
&#xD;
          -  Known GI disease or GI procedures that could interfere with the oral absorption,&#xD;
             excretion, or tolerance of alisertib.&#xD;
&#xD;
          -  History of urinary and/or fecal incontinence.&#xD;
&#xD;
          -  History of uncontrolled sleep apnea syndrome and other conditions that could result in&#xD;
             excessive daytime sleepiness such as severe chronic obstructive pulmonary disease.&#xD;
&#xD;
          -  Inability to swallow tablets, or inability or unwillingness to avoid taking anything&#xD;
             by mouth except for water and prescribed medications for 2 hours before and 1 hour&#xD;
             after the first dose of alisertib.&#xD;
&#xD;
          -  Inadequate bone marrow or other organ function as specified in study protocol.&#xD;
&#xD;
          -  Any cardiovascular condition specified in the study protocol.&#xD;
&#xD;
          -  Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface&#xD;
             antigen-positive status, or known or suspected active hepatitis C infection.&#xD;
&#xD;
          -  Inability to comply with study visits and procedures including required inpatient&#xD;
             confinement (approximately 11-17 days).&#xD;
&#xD;
        Please note that there are additional exclusion criteria. The study center will determine&#xD;
        if you meet all of the criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Clinical Development</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>February 20, 2018</results_first_submitted>
  <results_first_submitted_qc>February 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 31, 2018</results_first_posted>
  <last_update_submitted>February 20, 2018</last_update_submitted>
  <last_update_submitted_qc>February 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in the United States from 24 January 2013 to 14 June 2013.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of advanced solid tumors or lymphomas received [^14C]-alisertib 35 mg oral solution single dose in Part A and alisertib 50 mg for 7 days in 21-day cycles in Part B.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Alisertib</title>
          <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population included all participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Alisertib</title>
          <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.0" spread="13.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="173.5" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.27" spread="20.760"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.91" spread="8.346"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <population>Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>nanomole (nmol)/liter (L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alisertib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2183.3" spread="161.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Material</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2606.7" spread="228.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <population>Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>hr</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alisertib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="161.97" lower_limit="0.5" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Material</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="228.98" lower_limit="0.5" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>hour (hr)*nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alisertib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16800.0" spread="4936.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Material</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37033.3" spread="20545.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>hr*nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alisertib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17266.7" spread="5138.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Material</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42233.3" spread="23302.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alisertib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.40" spread="7.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related Material</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.03" spread="25.255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>L/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.06" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6550" spread="0.0671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8397" spread="0.0589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5950" spread="0.1010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast</title>
          <population>PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4997" spread="0.1364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6750" spread="0.0170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4490" spread="0.1204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>percent of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.650" spread="1.7935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>percent of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.833" spread="2.2898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ae: Amount of [^14C]-Alisertib Excreted in Urine</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ae: Amount of [^14C]-Alisertib Excreted in Urine</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>nanogram equivalent [ng(eq)]</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="939420.7" spread="632770.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ae: Amount of [^14C]-Alisertib Excreted in Feces</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ae: Amount of [^14C]-Alisertib Excreted in Feces</title>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>ng(eq)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31156703.0" spread="764243.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Total Radioactivity (TRA) in Urine and Feces</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Total Radioactivity (TRA) in Urine and Feces</title>
          <population>PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>percent of TRA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.500" spread="1.3115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fe: Fraction of Administered Dose of Alisertib Excreted in Urine</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>Participant from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Fe.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Fe: Fraction of Administered Dose of Alisertib Excreted in Urine</title>
          <population>Participant from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Fe.</population>
          <units>percent of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009045" spread="0.000714"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ae: Amount of Alisertib Excretion in Urine</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Ae.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Ae: Amount of Alisertib Excretion in Urine</title>
          <population>Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Ae.</population>
          <units>ng</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3215.0" spread="219.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Renal Clearance (CLR) of Alisertib</title>
        <time_frame>Predose and multiple timepoints post-dose (up to 240 hours)</time_frame>
        <population>Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data for CLR.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLR) of Alisertib</title>
          <population>Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data for CLR.</population>
          <units>L/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000687" spread="0.000013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.</description>
        <time_frame>Predose and multiple timepoints post-dose (0 to 192 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.</description>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>percent of plasma AUC0-192hr</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Metabolite M1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite M2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite M3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.</description>
        <time_frame>Predose and multiple timepoints post-dose (0 to 192 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.</description>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>percent of dose</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M8a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M536</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
        <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.</description>
        <time_frame>Predose and multiple timepoints post-dose (0 to 192 hours)</time_frame>
        <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution</title>
          <description>Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.</description>
          <population>PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.</population>
          <units>percent of dose</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M536</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M520a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M550</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M537</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M520b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M520c</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alisertib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events</title>
        <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)</time_frame>
        <population>Safety Population included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events</title>
          <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Population included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs</title>
        <description>An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.</description>
        <time_frame>Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)</time_frame>
        <population>Safety Population included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs</title>
          <description>An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.</description>
          <population>Safety Population included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Neutrophil Count Decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Magnesium Decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements</title>
        <description>Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.</description>
        <time_frame>Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)</time_frame>
        <population>Safety population included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Alisertib</title>
            <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements</title>
          <description>Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.</description>
          <population>Safety population included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Alisertib</title>
          <description>Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714947
org study id: C14014
secondary id: U1111-1187-6760
nct id: NCT01714947
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total
      radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in
      plasma and urine, and of TRA in plasma and whole blood.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested
      to treat participants who have advanced solid tumors or lymphomas. This study looked at mass
      balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.

      The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B.
      Participants received:

        -  [^14C]-alisertib 35 mg in Part A

        -  alisertib 50 mg in Part B

      Participants were asked to take a single dose of [^14C]-alisertib oral solution containing
      80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally,
      twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in
      Part B.

      This single center trial was conducted in United States. The overall time to participate in
      this study was up to 117 days. Participants remained confined to clinic in Part A and made
      multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose
      of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a
      final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up
      assessment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ae: Amount of [^14C]-Alisertib Excreted in Urine
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ae: Amount of [^14C]-Alisertib Excreted in Feces
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Percent of Total Radioactivity (TRA) in Urine and Feces
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Fe: Fraction of Administered Dose of Alisertib Excreted in Urine
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Ae: Amount of Alisertib Excretion in Urine
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Renal Clearance (CLR) of Alisertib
time frame: Predose and multiple timepoints post-dose (up to 240 hours)
measure: Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (0 to 192 hours)
description: Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.
measure: Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (0 to 192 hours)
description: Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.
measure: Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution
time frame: Predose and multiple timepoints post-dose (0 to 192 hours)
description: Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.
measure: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
time frame: From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)
description: An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs
time frame: Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)
description: An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.
measure: Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements
time frame: Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)
description: Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.
arm group label: Alisertib
arm group type: Experimental
description: Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1.
Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).
intervention type: Drug
intervention name: [^14C]-alisertib
description: [^14C]-alisertib oral solution
arm group label: Alisertib
other name: MLN8237
intervention type: Drug
intervention name: alisertib
description: Alisertib enteric coated tablets
arm group label: Alisertib
other name: MLN8237
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 