<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/NCT02235701</url>
  </required_header>
  <id_info>
    <org_study_id>ALDOXORUBICIN-P1/2-STS-03</org_study_id>
    <nct_id>NCT02235701</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma</brief_title>
  <official_title>An Open-Label Phase 1/2 Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma</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 study the safety and activity of aldoxorubicin with&#xD;
      ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2014</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>Phase 1/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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Measures</measure>
    <time_frame>14 months</time_frame>
    <description>The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor Response</measure>
    <time_frame>17 months</time_frame>
    <description>The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate and progression-free survival (PFS).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <description>administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days</description>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <description>administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days</description>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <description>administered 350 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days</description>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ifosfamide</intervention_name>
    <arm_group_label>aldoxorubicin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 15-80 years, male or female.&#xD;
&#xD;
          2. Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor&#xD;
             recurrence for at least 12 months since the last measurement, beginning or end of last&#xD;
             chemotherapy.&#xD;
&#xD;
          3. Histologically or cytologically confirmed, locally advanced, unresectable, and/or&#xD;
             metastatic soft tissue sarcoma (including rhabdomyosarcoma, Ewing's sarcoma and mixed&#xD;
             mesodermal sarcoma), chondrosarcoma or osteosarcoma of intermediate or high grade and&#xD;
             gastrointestinal stromal tumors (GIST) (only in subjects that have progressed after&#xD;
             receiving treatment with imatinib and sunitinib).&#xD;
&#xD;
          4. Capable of providing informed consent and complying with trial procedures.&#xD;
&#xD;
          5. ECOG performance status 0-2.&#xD;
&#xD;
          6. Life expectancy &gt;12 weeks.&#xD;
&#xD;
          7. Measurable tumor lesions according to RECIST 1.1 criteria.&#xD;
&#xD;
          8. Women must not be able to become pregnant (eg 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. Males and their female partner(s) of child-bearing potential must use 2 forms of&#xD;
             effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the&#xD;
             last menstrual period of the female partner during the study treatment and for 6&#xD;
             months after the final dose of study treatment.&#xD;
&#xD;
         10. 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;
         11. Geographic accessibility to the site that ensures the subject will be able to keep all&#xD;
             study-related appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence&#xD;
             for at least 12 months.&#xD;
&#xD;
          2. Prior exposure to &gt;3 cycles or 225 mg/m2 of doxorubicin or Doxil®.&#xD;
&#xD;
          3. Palliative surgery and/or radiation treatment less than 30 days prior to enrollment.&#xD;
&#xD;
          4. Exposure to any investigational agent within 30 days of enrollment.&#xD;
&#xD;
          5. Current Stage 1 or 2 soft tissue sarcomas.&#xD;
&#xD;
          6. Current evidence/diagnosis of alveolar soft part sarcoma, dermatofibrosarcoma,&#xD;
             Kaposi's sarcoma, clear cell sarcomas and unresectable low grade liposarcomas.&#xD;
&#xD;
          7. Central nervous system metastasis if symptomatic.&#xD;
&#xD;
          8. History of other malignancies except cured basal cell carcinoma, superficial bladder&#xD;
             cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥ 5&#xD;
             years.&#xD;
&#xD;
          9. Laboratory values: Screening serum creatinine &gt;1.5x upper limit of normal (ULN),&#xD;
             alanine aminotransferase (ALT) &gt; 3 × ULN or &gt;5 × ULN if liver metastases are present,&#xD;
             total bilirubin &gt;3 × ULN, absolute neutrophil count &lt;1,500/mm3, platelet concentration&#xD;
             &lt;100,000/mm3, hematocrit level &lt;25% for females or &lt;27% for males, albumin &lt;2 gm/dL,&#xD;
             coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT],&#xD;
             International Normalized Ratio [INR]) &gt;1.5 × ULN.&#xD;
&#xD;
         10. Clinically evident congestive heart failure &gt; class II of the New York Heart&#xD;
             Association (NYHA) guidelines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Levitt, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>CytRx Coporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sarcoma Oncology Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</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>soft tissue sarcoma</keyword>
  <keyword>aldoxorubicin</keyword>
  <keyword>ifosfamide</keyword>
  <keyword>mesna</keyword>
  <keyword>phase 1</keyword>
  <keyword>INNO-206</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ifosfamide</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
  </intervention_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/NCT02235701
org study id: ALDOXORUBICIN-P1/2-STS-03
nct id: NCT02235701
lead sponsor: 
has dmc: No
This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with
      ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety Measures
time frame: 14 months
description: The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.
measure: Tumor Response
time frame: 17 months
description: The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate and progression-free survival (PFS).
arm group label: aldoxorubicin
arm group type: Experimental
intervention type: Drug
intervention name: aldoxorubicin
description: administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
arm group label: aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: aldoxorubicin
description: administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
arm group label: aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: aldoxorubicin
description: administered 350 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
arm group label: aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: ifosfamide
arm group label: aldoxorubicin
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dan Levitt, M.D.
role: Study Director
affiliation: CytRx Coporation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Ifosfamide
mesh term: Doxorubicin