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NCT03637491 · ClinicalTrials.gov registry record · Phase 1
A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03637491: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT03637491 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03637491, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This Phase 1b/2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant solid tumors. The Phase 1b part of the study will assess if the different study drugs can be given together safely and which doses to use for further research. Phase 2 will test if the study treatments have an effect on tumor size and growth, and gather more information about potential side effects.
Primary Outcome
Any adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to study drugs and met DLT criteria. DLT was defined as hematologic: Grade 4 neutropenia lasting\>5 days; febrile neutropenia; neutropenic infection; Grade \>=3 thrombocytopenia with bleed; Grade 4 thrombocytopenia; Grade 4 anemia; non-hematologic: Grade ≥3 toxicities (with some exceptions) ; Grade≥3 creatinine phosphokinase (CPK) with creatinine \>= 1.5xbaseline; Grade 3 troponin increase with c
Interventions
- DRUG Talazoparib
- DRUG Avelumab
- DRUG Binimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 1 |
Why NCT03637491 stopped before completion
NCT03637491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Talazoparib is the first listed.
NCT03637491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03637491 about?
NCT03637491 is a clinical study titled "A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors". This Phase 1b/2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant solid tumors. The Phase 1b part of the study will assess if the different s...
What is the current status of trial NCT03637491?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-08-15. Estimated completion is 2021-02-02.
What interventions are being tested in trial NCT03637491?
The interventions under investigation include: Talazoparib (DRUG), Avelumab (DRUG), Binimetinib (DRUG).
Who is sponsoring clinical trial NCT03637491?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03637491's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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