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A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)

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ClinicalTrials.gov Identifier: NCT03449030
Recruitment Status : Terminated (Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.)
First Posted : February 28, 2018
Results First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE February 22, 2018
First Posted Date  ICMJE February 28, 2018
Results First Submitted Date  ICMJE February 24, 2021
Results First Posted Date  ICMJE March 22, 2021
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE April 23, 2018
Actual Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
  • Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Baseline up to Month 22 ]
    DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count [ANC] less than (<) 500 cells/cubic millimeter [mm^3]), thrombocytopenia (platelets <25,000/mm^3), febrile neutropenia (ANC <1000/mm^3) with fever (greater than [>] 38.3 degree Celsius or sustained temperature of greater than or equal to (>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (<1 week) Grade 3 fatigue.
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) ]
  • Percentage of Participants With Grade 3 or Above AEs [ Time Frame: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) ]
    AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: Death related AE. Higher grade indicates more severe condition.
  • Percentage of Participants With Drug-related AEs [ Time Frame: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) ]
  • Percentage of Participants With Drug-related Grade 3 or Above AEs [ Time Frame: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) ]
    AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition.
  • Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) ]
  • Percentage of Participants With AEs Leading to Discontinuation [ Time Frame: From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) ]
  • Recommended Phase 2 Dose (RP2D) of TAK-164 [ Time Frame: Baseline up to Month 22 ]
    RP2D was the highest safe dose that could be applied to the expansion phase.
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 36 months ]
    DLTs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03, defined as any of the following events: Grade 4 neutropenia; Grade 3 or greater neutropenia with fever and/or infection; Grade 4 thrombocytopenia; Grade 3 or greater thrombocytopenia with clinically meaningful bleeding; Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis; Grade 3 or greater diarrhea; Grade 3 or greater nonhematologic toxicity with the following exceptions: Brief (less than [<] 1 week) Grade 3 fatigue; TEAEs of Grade 2 or greater hematological or nonhematologic toxicities and an incomplete recovery from treatment-related toxicity causing a greater than (>) 2-week delay in the next scheduled injection before the initiation of next cycle will be considered a DLT.
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 36 months ]
  • Percentage of Participants with Grade 3 or Above AEs [ Time Frame: Up to 36 months ]
    AE Grades will be evaluated as per NCI CTCAE, version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
  • Percentage of Participants with Drug-related AEs [ Time Frame: Up to 36 months ]
  • Percentage of Participants with Drug-related Grade 3 or Above AEs [ Time Frame: Up to 36 months ]
  • Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 36 months ]
  • Percentage of Participants with AEs Leading to Discontinuation [ Time Frame: Up to 36 months ]
  • Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests Once Post Dose [ Time Frame: Up to 36 months ]
  • Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose [ Time Frame: Up to 36 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
  • Cmax: Maximum Observed Plasma Concentration for TAK-164 [ Time Frame: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) ]
  • Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164 [ Time Frame: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) ]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-164 [ Time Frame: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) ]
  • Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAK-164 [ Time Frame: Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) ]
  • Overall Response Rate (ORR) [ Time Frame: From start of study treatment until the start of subsequent anti cancer therapy ( up to Month 22) ]
    ORR was assessed by the investigator based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
  • Disease Control Rate (DCR) [ Time Frame: Baseline up to Month 22 ]
    DCR was defined as the percentage of participants with CR, PR or stable disease (SD). DCR was assessed based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
  • Duration of Response (DOR) [ Time Frame: From the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first (up to 22 months) ]
    DOR was defined as the time from the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first based on modified RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameters. PD was >=20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD.
  • Progression-free Survival (PFS) [ Time Frame: From date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first (up to 22 months) ]
    PFS was defined as the time from date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first according to modified RECIST version 1.1 criteria. PD was >= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD. PFS was censored at the last response assessment that is stable disease or better, prior to receipt of subsequent anticancer therapy, if applicable. Participants with no post-baseline assessments was censored at Day 1.
  • Number of Participants With Positive Antidrug Antibody (ADA) Levels in Serum [ Time Frame: Baseline up to Month 22 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Cmax: Maximum Observed Plasma Concentration for TAK-164 [ Time Frame: Cycle 1 and 2 Day 1 pre-dose and at multiple timepoints (up to 336 hours) post-dose ]
  • Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164 [ Time Frame: Cycle 1 and 2 Day 1 pre-dose and at multiple timepoints (up to 336 hours) post-dose ]
  • AUClast: Area Under the Plasma Concentration-time Curve from Time 0 to Time of Last Quantifiable Concentration for TAK-164 [ Time Frame: Cycle 1 and 2 Day 1 pre-dose and at multiple timepoints (up to 336 hours) post-dose ]
  • Ctrough: Observed Concentration Measured at the end of a Dosing Interval for TAK-164 [ Time Frame: Cycle 1 and 2 Day 1 pre-dose and at multiple timepoints (up to 336 hours) post-dose ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]
    ORR is defined as the percentage of participants with complete response (CR), or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is disappearance of all target lesions. PR is at least 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total representative of all involved organs were identified as target lesions at baseline. Target lesions were selected on the basis of size (longest lesions) and suitability for reproducible repeated measurements.
  • Disease Control Rate (DCR) [ Time Frame: Up to 36 months ]
    DCR is defined as the percentage of participants with CR, PR or stable disease (SD) with a minimum of 12 weeks duration. Duration of SD is defined as the time from the date of first study drug administration to the date of first documentation of disease progression for participants who achieved SD as the best overall response. CR is disappearance of all target lesions. PR is at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the baseline smallest sum of LD, since the treatment started or the appearance of one or more new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
  • Duration of Response (DOR) [ Time Frame: Up to 36 months ]
    DOR is defined as the time from the date of first documentation of a response to the date of first documentation of PD according to RECIST version 1.1 criteria. PD is defined as at least 20% increase in the sum of the LD of target lesions, taking as reference the baseline smallest sum of LD, since the treatment started or the appearance of one or more new lesions. Participants without documentation of PD at the time of analysis will be censored at the date of their last response assessment that is stable disease or better.
  • Progression-free Survival (PFS) [ Time Frame: Up to 36 months ]
    PFS is defined as the time from the date of first study drug administration to the date of first documentation of PD or death. PD is defined as at least 20% increase in the sum of the LD of target lesions, taking as reference the baseline smallest sum of LD, since the treatment started or the appearance of one or more new lesions. Participants without documentation of PD at the time of analysis will be censored at the date of their last response assessment that is SD or better.
  • Number of Participants with Antidrug Antibody (ADA) Levels in Serum [ Time Frame: Up to 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Official Title  ICMJE An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients With Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C
Brief Summary The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
Detailed Description

The drug being tested in this study is a novel antibody-drug conjugate (ADC) called TAK-164. TAK-164 is being evaluated in participants with advanced GCC-positive GI cancer (Part A) or colorectal carcinoma (CRC) and gastric carcinoma (Part B and Part C) to determine safety, tolerability, and pharmacokinetics (PK) and MTD/RP2D of TAK-164, as well as the preliminary efficacy. The study will include approximately 100 evaluable participants.

In Part A (Escalation), approximately 25 participants with GI carcinoma will be enrolled. Those include participants with various GI malignancies such as carcinomas of esophagus, stomach, colon, and pancreas. The starting dose for Arm 1 will be 0.004 mg/kg of TAK-164 administered intravenously on Day 1 Q3W and the maximal dose will not exceed 0.19 mg/kg Q3W.

In Part B (Expansion), approximately 50 participants will be enrolled to receive TAK-164 infusion at determined RP2D in Part A. Participants will follow the Q3W schedule and will be followed until PD, unacceptable toxicity, or until they choose to withdraw consent.

In Part C (Imaging substudy to be conducted in the Netherlands only), approximately 25 participants with GCC-expressing metastatic colorectal carcinoma (mCRC) will be enrolled to receive 89Zr-TAK-164 and unlabeled TAK-164 at determined RP2D in Part A.

This multi-center trial will be conducted in the United States and the Netherlands. The overall time to participate in this study is up to 55 months. Participants will attend an end of study (EOS) visit 30 days after the last dose of TAK-164 or just prior to the start of subsequent antineoplastic therapy, whichever occurs first.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
Intervention  ICMJE
  • Drug: TAK-164
    TAK-164 intravenous infusion.
  • Drug: 89Zr-TAK-164
    89Zr-TAK-164 intravenous infusion
Study Arms  ICMJE
  • Experimental: Part A Escalation Stage: TAK-164 Q3W
    TAK-164 0.004 milligram per kilogram (mg/kg) starting dose, intravenous infusion, until PD, unacceptable toxicity or discontinuation by participant. Dose escalation will be performed to determine the MTD and/or RP2D.
    Intervention: Drug: TAK-164
  • Experimental: Part B Expansion Stage: TAK-164 Q3W
    TAK-164, intravenous infusion, until PD, unacceptable toxicity or discontinuation by participant. TAK-164 RP2D dose to be decided based on safety, PK, pharmacodynamics and antitumor response data observed in Part A escalation stage.
    Intervention: Drug: TAK-164
  • Experimental: Part C Imaging Substudy: 89Zr-TAK-164 and TAK-164
    89Zr-TAK-164, intravenous infusion, followed by unlabeled TAK-164, intravenous infusion in combination with 89Zr-TAK-164, intravenous infusion, and further followed by unlabeled TAK-164, intravenous infusion, until PD, unacceptable toxicity or discontinuation by participant. TAK-164 recommended imaging dose (RID) or RP2D dose to be decided based on safety, PK, PD and antitumor response data observed in Part A escalation stage.
    Interventions:
    • Drug: TAK-164
    • Drug: 89Zr-TAK-164
Publications * Abu-Yousif AO, Cvet D, Gallery M, Bannerman BM, Ganno ML, Smith MD, Lai KC, Keating TA, Stringer B, Kamali A, Eng K, Koseoglu S, Zhu A, Xia CQ, Landen MS, Borland M, Robertson R, Bolleddula J, Qian MG, Fretland J, Veiby OP. Preclinical Antitumor Activity and Biodistribution of a Novel Anti-GCC Antibody-Drug Conjugate in Patient-derived Xenografts. Mol Cancer Ther. 2020 Oct;19(10):2079-2088. doi: 10.1158/1535-7163.MCT-19-1102. Epub 2020 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 21, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2018)
95
Actual Study Completion Date  ICMJE February 27, 2020
Actual Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or cytologically confirmed measurable advanced and/or metastatic solid GI tumor that expresses GCC protein (H-score greater than or equal to [>=] 10), for which standard treatment is no longer effective or does not offer curative or life-prolonging benefit. For the escalation part of the study (Part A), GI malignancies include, but are not limited to, metastatic colorectal carcinoma (mCRC), gastric carcinoma, esophageal carcinoma, small intestine cancer, and pancreatic cancer. The expansion part of the study (Part B) is limited to participants with CRC expressing a high-level of GCC (H-Score >=150) and gastric carcinoma (H-Score >=10). Part C includes participants with CRC and gastric carcinoma (H-score >=10 for both indications).

    o Part B of the study will be limited to participants with 2 or 3 prior lines of systemic standard of care therapy.

  2. Male or female participants 18 years or older.
  3. Adequate bone marrow function, defined as an absolute neutrophil count (ANC) of >=1.5*10^9 per liter (/L), platelet count >=100*10^9/L, and hemoglobin >=9 gram per deciliter (g/dL). Receiving transfusions or hematopoietic growth factors to meet enrollment criteria is not allowed within 14 days preceding the first dose of study drug.
  4. Adequate hepatic function with total bilirubin less than or equal to (<=) 1.5* upper limit of normal (ULN), serum ALT and AST must be less than (<) 2.5*ULN (AST and ALT may be elevated up to 3*ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver), serum albumin > 3.0 g/dL.
  5. Adequate renal function as defined by creatinine CL >= 60 milliliter per minute (mL/min).
  6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
  7. Life expectancy of at least 12 weeks.
  8. Completion of prior chemotherapy, biologic therapy, immunotherapy, or radiation therapy at least 4 weeks prior to enrollment.
  9. Resolution of all toxic effects of prior treatments (except alopecia) to Grade <=1 NCI CTCAE, version 5.
  10. A portion of participants should have tumors amenable for serial biopsy and a willingness to provide consent for pharmacodynamic assessment.

    Additionally for Part C (imaging sub study), participant must fulfill the following criteria:

  11. At least 1 extrahepatic metastatic lesion >=2 centimeter (cm) in the longest diameter.

Exclusion Criteria:

  1. Treatment with anticancer chemotherapy or biologic therapy or with an experimental anticancer agent within 28 days of the initial dose of study drug.
  2. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  3. Participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in TAK-164 formulation or 89Zr-TAK-164 formulation.
  4. Use of strong cytochrome P3A (CYP3A) inhibitors and CYP3A inducers or inhibitors or modulators of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 1 week before the first dose of study drug.
  5. For participants enrolled in studies in which tumor biopsies are obtained:

    • Known bleeding diathesis or history of abnormal bleeding, or any other known coagulation abnormalities that would contraindicate the tumor biopsy procedure.
    • Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, heparin, or warfarin).
  6. Participant has concurrent alcohol abuse or a history of drug-induced liver injury (DILI).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03449030
Other Study ID Numbers  ICMJE TAK-164-1001
U1111-1207-9923 ( Other Identifier: WHO )
2018-002214-12 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/
Responsible Party Takeda ( Millennium Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Millennium Pharmaceuticals, Inc.
PRS Account Takeda
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP