<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/NCT01706835</url>
  </required_header>
  <id_info>
    <org_study_id>ALDOXORUBICIN-P1-PK-01</org_study_id>
    <nct_id>NCT01706835</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors</brief_title>
  <official_title>An Open-Lable Phase 1 Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImmunityBio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ImmunityBio, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin&#xD;
      administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with&#xD;
      advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An Open-Label Phase 1 Study to Investigate the Pharmacokinetics of Aldoxorubicin Administered&#xD;
      as a 30 Minute Infusion Every 3 Weeks in Subjects with Advanced Solid Tumors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Pharmacokinetics</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>up to 6 months</time_frame>
    <description>All subjects who receive any amount of aldoxorubicin will be included in the safety analyses, which will include the following:&#xD;
The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.&#xD;
Deaths and other SAEs will be tabulated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Aldoxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aldoxorubicin dosages of 230 mg/m2 or 350 mg/m2 will be given as a 30 minute infusion every 3 weeks for 8 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <arm_group_label>Aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years, male or female.&#xD;
&#xD;
          2. Histologically or cytologically confirmed malignant solid tumor that has relapsed or&#xD;
             is refractory to standard therapy.&#xD;
&#xD;
          3. Subjects who have received prior radiation therapy with stable central nervous system&#xD;
             (CNS) metastasis with no progression of brain metastasis by CT/MRI scan in last 4&#xD;
             weeks.&#xD;
&#xD;
          4. Capable of providing informed consent and complying with trial procedures.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.&#xD;
&#xD;
          6. Life expectancy &gt;12 weeks.&#xD;
&#xD;
          7. Measurable or evaluable disease.&#xD;
&#xD;
          8. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year,&#xD;
             surgically sterile, or practicing adequate birth control methods) for the duration of&#xD;
             the study. [Adequate contraception includes: oral contraception, implanted&#xD;
             contraception, intrauterine device implanted for at least 3 months, or barrier method&#xD;
             in conjunction with spermicide.].&#xD;
&#xD;
          9. Women of child bearing potential must have a negative serum or urine pregnancy test at&#xD;
             the Screening Visit and be non-lactating.&#xD;
&#xD;
         10. Geographic accessibility to the site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment less than 4&#xD;
             weeks prior to the Screening Visit.&#xD;
&#xD;
          2. Exposure to any investigational agent within 30 days of the Screening Visit.&#xD;
&#xD;
          3. Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL,&#xD;
             alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or&#xD;
             5 times the ULN in liver metastases, total bilirubin greater than 3 times the ULN,&#xD;
             white blood cell (WBC) count &lt;3500/mm3, absolute neutrophil (ANC) count &lt; 2000/mm3,&#xD;
             platelet concentration &lt;100,000/mm3, hematocrit level &lt;25% for females or &lt;28% for&#xD;
             males (transfusion is allowed during screening).&#xD;
&#xD;
          4. Clinically evident congestive heart failure (CHF) &gt; class II of the New York Heart&#xD;
             Association (NYHA) guidelines.&#xD;
&#xD;
          5. Serious, clinically significant cardiac arrhythmias, defined as the existence of an&#xD;
             absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.&#xD;
&#xD;
          6. Recent history (within 6 months) or current signs of active coronary artery disease&#xD;
             with or without angina pectoris.&#xD;
&#xD;
          7. Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)&#xD;
             or ultrasound determined absolute left ventricular ejection fraction (LVEF) &lt;45% of&#xD;
             predicted.&#xD;
&#xD;
          8. Known history of HIV infection.&#xD;
&#xD;
          9. Active, clinically significant serious infection requiring treatment with antibiotics,&#xD;
             antivirals or antifungals.&#xD;
&#xD;
         10. Major surgery within 4 weeks prior to treatment.&#xD;
&#xD;
         11. Substance abuse or any condition that might interfere with the subject's participation&#xD;
             in the study or in the evaluation of the study results.&#xD;
&#xD;
         12. Any condition that is unstable and could jeopardize the subject's participation in the&#xD;
             study.&#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>Dan Levitt, MD</last_name>
    <role>Study Director</role>
    <affiliation>CytRx Coorporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samuel Oschin Comprehensive Cancer Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>solid tumor</keyword>
  <keyword>aldoxorubicin</keyword>
  <keyword>phase 1</keyword>
  <keyword>pharmacokinetic</keyword>
  <keyword>INNO-206</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01706835
org study id: ALDOXORUBICIN-P1-PK-01
nct id: NCT01706835
lead sponsor: 
has dmc: No
This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin
      administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with
      advanced solid tumors.
An Open-Label Phase 1 Study to Investigate the Pharmacokinetics of Aldoxorubicin Administered
      as a 30 Minute Infusion Every 3 Weeks in Subjects with Advanced Solid Tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics
time frame: up to 3 months
description: Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.
measure: Safety
time frame: up to 6 months
description: All subjects who receive any amount of aldoxorubicin will be included in the safety analyses, which will include the following:
The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.
Deaths and other SAEs will be tabulated.
arm group label: Aldoxorubicin
arm group type: Experimental
description: Aldoxorubicin dosages of 230 mg/m2 or 350 mg/m2 will be given as a 30 minute infusion every 3 weeks for 8 cycles.
intervention type: Drug
intervention name: aldoxorubicin
arm group label: Aldoxorubicin
other name: INNO-206
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dan Levitt, MD
role: Study Director
affiliation: CytRx Coorporation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms