xml: <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/NCT05976334</url>
    </required_header>
    <id_info>
      <org_study_id>TAK-981-1004</org_study_id>
      <secondary_id>2023-503449-79</secondary_id>
      <nct_id>NCT05976334</nct_id>
    </id_info>
    <brief_title>An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors</brief_title>
    <official_title>A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Takeda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Takeda</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main aim of this study is to assess how the human body of adults with advanced or&#xD;
        metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following&#xD;
        a single 1 hour infusion of subasumstat.&#xD;
  &#xD;
        The study consists of two parts. In Part A, participants will receive a single infusion of&#xD;
        C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for&#xD;
        up to 1 year.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The drug being tested in this study is called [14C]subasumstat. [14C]Subasumstat is being&#xD;
        tested to assess mass balance and absorption, distribution, metabolism, excretion (ADME) of&#xD;
        people who have advanced or metastatic solid tumors.&#xD;
  &#xD;
        The study will enroll approximately 10 patients. Participants will be enrolled to receive a&#xD;
        single dose of [14C]subasumstat:&#xD;
  &#xD;
        - [14C]Subasumstat 90 mg&#xD;
  &#xD;
        Participants will be administered with a single dose of [14C]subasumstat 90 mg as a 1-hour&#xD;
        intravenous (IV) infusion on Day 1 of Part A. All participants will be monitored for up to 14&#xD;
        days postdose. Participants will then have an option to enter Part B of the study to receive&#xD;
        non-radiolabelled subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
        for 3 cycles up to maximum treatment duration of 1 year.&#xD;
  &#xD;
        This multi-center trial will be conducted in Hungary. The overall study duration is 12 months&#xD;
        for Part A and 24 months for Part B.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</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>Cumulative Percentage of Urinary Recovery</measure>
      <time_frame>Up to 14 days postdose</time_frame>
      <description>Cumulative amount of [14C]-radioactivity excreted in urine up to the last sampling interval.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cumulative Percentage of Fecal Recovery</measure>
      <time_frame>Up to 14 days postdose</time_frame>
      <description>Cumulative amount of [14C]-radioactivity excreted in feces up to the last sampling interval.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cumulative Percentage of Combined Recovery</measure>
      <time_frame>Up to 14 days postdose</time_frame>
      <description>Cumulative amount of [14C]-radioactivity excreted in urine, and feces up to the last sampling interval.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage Of Recovered Total Radioactivity (TRA) In Urine And Feces</measure>
      <time_frame>Up to 14 days postdose</time_frame>
      <description>Percentage of recovered TRA in urine and feces for each interval over the entire period of collection will be reported.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data</measure>
      <time_frame>Predose on Day 1 and at multiple time postdose points up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative Amount of Unchanged Subasumstat and TRA Excreted into the Urine (Aeurine)</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renal Clearance (CLR) for Subasumstat and TRA in Urine</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With One or More Adverse Events (AEs)</measure>
      <time_frame>From the start of study drug administration through 30 days after the last dose of study drug (up to approximately 1 year)</time_frame>
      <description>An Adverse Event (AE) is 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With One or More Serious Adverse Events (SAEs)</measure>
      <time_frame>From the start of study drug administration through 30 days after the last dose of study drug (up to approximately 1 year)</time_frame>
      <description>An AE is 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 SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Abnormal Electrocardiogram Findings</measure>
      <time_frame>From the start of study drug administration through the last dose of study drug (up to approximately 1 year)</time_frame>
      <description>Abnormal laboratory values are those outside of normal range as assessed by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Abnormal Laboratory Values</measure>
      <time_frame>From the start of study drug administration through the last dose of study drug (up to approximately 1 year)</time_frame>
      <description>Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative Percentage of Circulatory Metabolites in Plasma</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative Percentage Excretory Metabolites in Urine</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relative Percentage Excretory Metabolites in Feces</measure>
      <time_frame>Predose on Day 1 and at multiple time points postdose up to Day 14</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Solid Tumors</condition>
    <arm_group>
      <arm_group_label>[14C] Subasumstat 90 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of [14C] Subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Following Part A, participants will have an option to receive subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[14C] Subasumstat</intervention_name>
      <description>[14C] Subasumstat IV infusion.</description>
      <arm_group_label>[14C] Subasumstat 90 mg</arm_group_label>
      <other_name>TAK-981</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Subasumstat</intervention_name>
      <description>Subasumstat IV infusion.</description>
      <arm_group_label>[14C] Subasumstat 90 mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Participants have histologically or cytologically confirmed advanced (locally&#xD;
               regionally recurrent not amenable to curative therapy) or metastatic solid tumors with&#xD;
               no standard therapeutic option with a proven clinical benefit, are intolerant or have&#xD;
               refused them.&#xD;
  &#xD;
            2. Participants have a performance status of 0 or 1 on the Eastern Cooperative Oncology&#xD;
               Group Performance Scale.&#xD;
  &#xD;
            3. Participants demonstrate adequate organ function.&#xD;
  &#xD;
            4. Participants have recovered to Grade 1 or baseline from all toxicity associated with&#xD;
               previous therapy or have the toxicity established as sequela.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Participants received treatment with radioisotopes within 5 half-lives before the&#xD;
               first dose of the study drug.&#xD;
  &#xD;
            2. Participants received radiolabelled substances, were exposed to radiation sources&#xD;
               within 12 months of the first dose in this study, or is likely to receive radiation&#xD;
               exposure or radioisotopes within 12 months of the first dose in this study such that&#xD;
               participation in this study would increase their total exposure beyond the recommended&#xD;
               safe levels.&#xD;
  &#xD;
            3. Participants received extended field radiotherapy ≤4 weeks before the start of&#xD;
               treatment.&#xD;
  &#xD;
            4. Participants have uncontrolled brain metastasis. Participants with treated brain&#xD;
               metastases are allowed provided they are radiologically stable, without evidence of&#xD;
               progression for at least 4 weeks by repeat imaging, clinically stable, and without&#xD;
               requirement of steroid treatment for at least 14 days before first dose of study&#xD;
               treatment.&#xD;
  &#xD;
            5. Participants had a second malignancy within the previous 3 years, except treated basal&#xD;
               cell or localized squamous skin carcinomas, prostate cancer, cervical carcinoma in&#xD;
               situ, resected colorectal adenomatous polyps, breast cancer in situ, or other&#xD;
               malignancy for which the patient is not on active anticancer therapies.&#xD;
  &#xD;
            6. Major surgery ≤14 days from the first dose of study drug and not recovered fully from&#xD;
               any complications from surgery.&#xD;
  &#xD;
            7. Baseline prolongation of the QT interval when corrected using Fridericia's formula&#xD;
               (QTcF).&#xD;
  &#xD;
            8. Receiving or requires the continued use of medications that are known to be strong or&#xD;
               moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strong&#xD;
               P-glycoprotein (Pgp) inhibitors.&#xD;
  &#xD;
            9. Has active noninfectious pneumonitis or interstitial lung disease that required&#xD;
               steroids.&#xD;
  &#xD;
           10. History of allogeneic tissue or solid organ transplant.&#xD;
  &#xD;
           11. Participants have active bacterial infection requiring systemic therapy &lt;14 days&#xD;
               before the start of treatment.&#xD;
  &#xD;
           12. Participants have an active HIV or any other relevant congenital or acquired&#xD;
               immunodeficiency.&#xD;
  &#xD;
           13. Active hepatitis B, or hepatitis C infection.&#xD;
  &#xD;
           14. Any of the following uncontrolled heart diseases: congestive heart failure New York&#xD;
               Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable&#xD;
               symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate&#xD;
               medical therapy, ongoing symptomatic cardiac arrhythmias &gt;Grade 2, pulmonary embolism&#xD;
               or symptomatic cerebrovascular events, or any other serious cardiac condition (eg,&#xD;
               pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on&#xD;
               stable anticoagulant therapy is allowed.&#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>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Takeda</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Takeda Contact</last_name>
      <phone>+1-877-825-3327</phone>
      <email>medinfoUS@takeda.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Central Hospital of Northern Pest - Military Hospital</name>
        <address>
          <city>Budapest</city>
          <zip>1062</zip>
          <country>Hungary</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
        <phone>+36308281059</phone>
        <email>trial.zspapai@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Zsuzsanna Papai</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Pharmaceutical Research Associates Magyarorszag</name>
        <address>
          <city>Budapest</city>
          <zip>1077</zip>
          <country>Hungary</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
        <phone>+36308281059</phone>
        <email>trial.zspapai@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Zsuzsanna Papai</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Hungary</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</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>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976334
  org study id: TAK-981-1004
  secondary id: 2023-503449-79
  nct id: NCT05976334
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The main aim of this study is to assess how the human body of adults with advanced or
        metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following
        a single 1 hour infusion of subasumstat.
  
        The study consists of two parts. In Part A, participants will receive a single infusion of
        C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for
        up to 1 year.
  The drug being tested in this study is called [14C]subasumstat. [14C]Subasumstat is being
        tested to assess mass balance and absorption, distribution, metabolism, excretion (ADME) of
        people who have advanced or metastatic solid tumors.
  
        The study will enroll approximately 10 patients. Participants will be enrolled to receive a
        single dose of [14C]subasumstat:
  
        - [14C]Subasumstat 90 mg
  
        Participants will be administered with a single dose of [14C]subasumstat 90 mg as a 1-hour
        intravenous (IV) infusion on Day 1 of Part A. All participants will be monitored for up to 14
        days postdose. Participants will then have an option to enter Part B of the study to receive
        non-radiolabelled subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21-day cycle
        for 3 cycles up to maximum treatment duration of 1 year.
  
        This multi-center trial will be conducted in Hungary. The overall study duration is 12 months
        for Part A and 24 months for Part B.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cumulative Percentage of Urinary Recovery
  time frame: Up to 14 days postdose
  description: Cumulative amount of [14C]-radioactivity excreted in urine up to the last sampling interval.
  measure: Cumulative Percentage of Fecal Recovery
  time frame: Up to 14 days postdose
  description: Cumulative amount of [14C]-radioactivity excreted in feces up to the last sampling interval.
  measure: Cumulative Percentage of Combined Recovery
  time frame: Up to 14 days postdose
  description: Cumulative amount of [14C]-radioactivity excreted in urine, and feces up to the last sampling interval.
  measure: Percentage Of Recovered Total Radioactivity (TRA) In Urine And Feces
  time frame: Up to 14 days postdose
  description: Percentage of recovered TRA in urine and feces for each interval over the entire period of collection will be reported.
  measure: Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
  time frame: Predose on Day 1 and at multiple time postdose points up to Day 14
  measure: Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Cumulative Amount of Unchanged Subasumstat and TRA Excreted into the Urine (Aeurine)
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Renal Clearance (CLR) for Subasumstat and TRA in Urine
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Number of Participants With One or More Adverse Events (AEs)
  time frame: From the start of study drug administration through 30 days after the last dose of study drug (up to approximately 1 year)
  description: An Adverse Event (AE) is 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.
  measure: Number of Participants With One or More Serious Adverse Events (SAEs)
  time frame: From the start of study drug administration through 30 days after the last dose of study drug (up to approximately 1 year)
  description: An AE is 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 SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
  measure: Number of Participants With Abnormal Electrocardiogram Findings
  time frame: From the start of study drug administration through the last dose of study drug (up to approximately 1 year)
  description: Abnormal laboratory values are those outside of normal range as assessed by the investigator.
  measure: Number of Participants With Abnormal Laboratory Values
  time frame: From the start of study drug administration through the last dose of study drug (up to approximately 1 year)
  description: Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator.
  measure: Relative Percentage of Circulatory Metabolites in Plasma
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Relative Percentage Excretory Metabolites in Urine
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  measure: Relative Percentage Excretory Metabolites in Feces
  time frame: Predose on Day 1 and at multiple time points postdose up to Day 14
  arm group label: [14C] Subasumstat 90 mg
  arm group type: Experimental
  description: Participants will receive a single dose of [14C] Subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Following Part A, participants will have an option to receive subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
  intervention type: Drug
  intervention name: [14C] Subasumstat
  description: [14C] Subasumstat IV infusion.
  arm group label: [14C] Subasumstat 90 mg
  other name: TAK-981
  intervention type: Drug
  intervention name: Subasumstat
  description: Subasumstat IV infusion.
  arm group label: [14C] Subasumstat 90 mg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Study Director
  role: Study Director
  affiliation: Takeda
  last name: Takeda Contact
  phone: +1-877-825-3327
  email: medinfoUS@takeda.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: Hungary
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: Yes
  ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
  ipd url: https://vivli.org/ourmember/takeda/