<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/NCT03008213</url>
  </required_header>
  <id_info>
    <org_study_id>UCSD</org_study_id>
    <nct_id>NCT03008213</nct_id>
  </id_info>
  <brief_title>Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV</brief_title>
  <acronym>CINV</acronym>
  <official_title>Fixed Dose Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory Chemotherapy-Induced Nausea and Vomiting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph Ma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important&#xD;
      in treatment of cancer patients. CINV is one of the most distressing severe side effects of&#xD;
      cancer treatment and can have a significant impact on a patient's quality of life. The&#xD;
      chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into&#xD;
      two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy&#xD;
      (HEC). Nausea and vomiting that occurs within the first day of the administration of&#xD;
      chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of&#xD;
      the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs&#xD;
      when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing&#xD;
      vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in&#xD;
      earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the&#xD;
      treatment of refractory CINV&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, single-center, single-arm, open-label, feasibility trial using a fixed&#xD;
      dose combination of netupitant and palonosetron (Akynzeo®) in the treatment of refractory&#xD;
      CINV. The primary aim of this study is feasibility, defined as 70% completion rate of all&#xD;
      study procedures over 7 days.&#xD;
&#xD;
      Eligible subjects will be identified in weekly palliative care patient triage meetings.&#xD;
      Patients who are 18 years of age or older, have histologically confirmed cancer, and&#xD;
      confirmed refractory CINV will be eligible. After obtaining written informed consent and&#xD;
      verifying that the study subject meets all eligibility criteria, the subject will be enrolled&#xD;
      in the study through the University California San Diego (UCSD) Moores Cancer Center Clinical&#xD;
      Trials Office. Subjects will be allowed to participate only once in the study. Study Day 1&#xD;
      will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300&#xD;
      mg of netupitant and 0.5 mg of palonosetron) on Study 1. Study drug may be taken with or&#xD;
      without food. Subjects will complete a study drug diary to document date and time of Akynzeo®&#xD;
      administration. On Study Day 1, the study coordinator will educate the subject on how to&#xD;
      complete the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool,&#xD;
      and Functional Living Index Emesis (FLIE) scale, and medication diary and each of these&#xD;
      documents will be completed for that day. An adequate number of copies of each subject&#xD;
      questionnaire and diary will be provided to the subject on Study Day 1 for completion at home&#xD;
      during the post-treatment observation portion of the study (Study Days 2-7) as needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI is leaving UCSD&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">January 22, 2018</completion_date>
  <primary_completion_date type="Actual">January 22, 2018</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Completed All Study Procedures Over Seven Days</measure>
    <time_frame>Through study completion, 7 days</time_frame>
    <description>The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.&#xD;
For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Chemotherapy Induced Nausea Vomiting</condition>
  <arm_group>
    <arm_group_label>Netupitant and Palonosetron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Netupitant and Palonosetron</intervention_name>
    <description>300 mg of netupitant and 0.5 mg of palonosetron</description>
    <arm_group_label>Netupitant and Palonosetron</arm_group_label>
    <other_name>Akynzeo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults greater than or equal to 18 years old.&#xD;
&#xD;
          2. Must have a histologically confirmed cancer diagnosis.&#xD;
&#xD;
          3. Must have refractory CINV defined as nausea and/or vomiting that occurs after the&#xD;
             first cycle of chemotherapy despite guideline-based prophylaxis and after first-line&#xD;
             rescue medication with either a dopamine receptor antagonist, steroid, and/or&#xD;
             benzodiazepine.&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.&#xD;
&#xD;
          5. Life expectancy greater than 3 months.&#xD;
&#xD;
          6. Corrected serum calcium level less than or equal to 10.5 mg/dL.&#xD;
&#xD;
          7. Women of child-bearing potential must agree to use adequate contraception (hormonal or&#xD;
             barrier method of birth control; abstinence) prior to study entry, for the duration of&#xD;
             study participation, and for 14 days following completion of therapy.&#xD;
&#xD;
             A) A woman of child-bearing potential is any female (regardless of sexual orientation,&#xD;
             having undergone a tubal ligation, or remaining celibate by choice) who meets the&#xD;
             following criteria:&#xD;
&#xD;
             i) Has not undergone a hysterectomy or bilateral oophorectomy; or ii) Has not been&#xD;
             naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses&#xD;
             at any time in the preceding 12 consecutive months)&#xD;
&#xD;
          8. Women of child-bearing potential must have a negative pregnancy test prior to&#xD;
             initiating study treatment.&#xD;
&#xD;
          9. Ability to understand and willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with QTc interval greater than 450 ms.&#xD;
&#xD;
          2. Patients with a known hypersensitivity reaction to 5-HT3 receptor antagonists or NK1&#xD;
             receptor antagonists.&#xD;
&#xD;
          3. Patients who have taken any medication classified as a strong CYP3A4 inducer within&#xD;
             one week of Study Day 1 or 5 halflives (whichever is longer) or use of a strong or&#xD;
             moderate CYP3A4 inhibitor within one week of Study Day 1 or 5 halflives (whichever is&#xD;
             longer) (see Appendix 2).&#xD;
&#xD;
          4. Patients with severe hepatic impairment as defined as AST/ALT greater than three times&#xD;
             the upper limit of normal, total bilirubin greater than 3 mg/dL, and/or Child-Pugh&#xD;
             score &gt;9.&#xD;
&#xD;
          5. Patients with end-stage renal disease defined as creatinine clearance of &lt;15mL/min&#xD;
             and/or diagnosed with Stage 5 chronic kidney disease.&#xD;
&#xD;
          6. Pregnant or lactating females are excluded from enrollment on this trial.&#xD;
&#xD;
          7. Patients unable to swallow oral medications. Any other condition that, in the opinion&#xD;
             of the investigator, may impact the absorption of oral medications.&#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>Joseph Ma, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>April 19, 2019</results_first_submitted>
  <results_first_submitted_qc>April 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 9, 2019</results_first_posted>
  <last_update_submitted>December 5, 2019</last_update_submitted>
  <last_update_submitted_qc>December 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Joseph Ma</investigator_full_name>
    <investigator_title>Associate Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Palonosetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03008213/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Netupitant and Palonosetron</title>
          <description>Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.&#xD;
Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Netupitant and Palonosetron</title>
          <description>Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.&#xD;
Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Completed All Study Procedures Over Seven Days</title>
        <description>The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.&#xD;
For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.</description>
        <time_frame>Through study completion, 7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Netupitant and Palonosetron</title>
            <description>Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.&#xD;
Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completed All Study Procedures Over Seven Days</title>
          <description>The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.&#xD;
For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Netupitant and Palonosetron</title>
          <description>Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.&#xD;
Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eric Roeland, MD</name_or_title>
      <organization>UCSD</organization>
      <phone>858- 534-7079</phone>
      <email>eroeland@ucsd.edu</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/NCT03008213
org study id: UCSD
nct id: NCT03008213
lead sponsor: 
has dmc: Yes
Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important
      in treatment of cancer patients. CINV is one of the most distressing severe side effects of
      cancer treatment and can have a significant impact on a patient's quality of life. The
      chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into
      two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy
      (HEC). Nausea and vomiting that occurs within the first day of the administration of
      chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of
      the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs
      when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing
      vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in
      earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the
      treatment of refractory CINV
This is a Phase II, single-center, single-arm, open-label, feasibility trial using a fixed
      dose combination of netupitant and palonosetron (Akynzeo®) in the treatment of refractory
      CINV. The primary aim of this study is feasibility, defined as 70% completion rate of all
      study procedures over 7 days.

      Eligible subjects will be identified in weekly palliative care patient triage meetings.
      Patients who are 18 years of age or older, have histologically confirmed cancer, and
      confirmed refractory CINV will be eligible. After obtaining written informed consent and
      verifying that the study subject meets all eligibility criteria, the subject will be enrolled
      in the study through the University California San Diego (UCSD) Moores Cancer Center Clinical
      Trials Office. Subjects will be allowed to participate only once in the study. Study Day 1
      will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300
      mg of netupitant and 0.5 mg of palonosetron) on Study 1. Study drug may be taken with or
      without food. Subjects will complete a study drug diary to document date and time of Akynzeo®
      administration. On Study Day 1, the study coordinator will educate the subject on how to
      complete the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool,
      and Functional Living Index Emesis (FLIE) scale, and medication diary and each of these
      documents will be completed for that day. An adequate number of copies of each subject
      questionnaire and diary will be provided to the subject on Study Day 1 for completion at home
      during the post-treatment observation portion of the study (Study Days 2-7) as needed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Completed All Study Procedures Over Seven Days
time frame: Through study completion, 7 days
description: The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.
For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.
arm group label: Netupitant and Palonosetron
arm group type: Experimental
description: Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.
intervention type: Drug
intervention name: Netupitant and Palonosetron
description: 300 mg of netupitant and 0.5 mg of palonosetron
arm group label: Netupitant and Palonosetron
other name: Akynzeo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Ma, PharmD
role: Principal Investigator
affiliation: UCSD
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, San Diego
investigator full name: Joseph Ma
investigator title: Associate Clinical Professor
mesh term: Nausea
mesh term: Vomiting
mesh term: Palonosetron
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 