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NCT04381650 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 161
- Enrollment target
- 20
- Study locations
NCT04381650: Completed Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Takeda.
NCT04381650 is a Phase 1 study of Advanced or Metastatic Solid Tumors that has completed, run by Takeda. The registered enrollment target is 161 participants, below the 229-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04381650, a Phase 1 study of Advanced or Metastatic Solid Tumors, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 161 participants
- Enrollment target
- 20
- Study locations
Study Summary
TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. AEs were evaluated according to National Cancer Institute Common Terminology Criteri
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG TAK-981
Study Locations (20)
California
- University of California Irvine Medical Center - Orange
- Stanford Cancer Institute (SCI) - Stanford
New Jersey
- Morristown Medical Center - Morristown
- Cancer Institute of New Jersey - New Brunswick
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
- UPMC Hillman Cancer Center - Pittsburgh
Texas
- University of Texas Southwestern Medical Center - Dallas
- START South Texas Accelerated Research Therapeutics - San Antonio
Virginia
- University of Virginia Health System - Charlottesville
- Virginia Cancer Specialists (Fairfax) - USOR - Fairfax
Arizona
- HonorHealth - Scottsdale
Connecticut
- Yale Cancer Center - New Haven
Georgia
- Georgia Cancer Center at Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-08-17 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 1 |
What the finished NCT04381650 record still lists
NCT04381650 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 229-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04381650 names 20 study sites across 15 states, led by California, New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04381650 about?
NCT04381650 is a clinical study titled "A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors". TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combinat...
What is the current status of trial NCT04381650?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 161 participants. The study started on 2020-08-17. Estimated completion is 2024-10-29.
What conditions does trial NCT04381650 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT04381650?
The interventions under investigation include: Pembrolizumab (DRUG), TAK-981 (DRUG).
Who is sponsoring clinical trial NCT04381650?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04381650 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04381650's enrollment target sits among peer trials
161 11th of 19 higher than 9 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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