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NCT03981614 · ClinicalTrials.gov registry record · Phase 2
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
A Phase 2 study, sponsored by Academic and Community Cancer Research United.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT03981614: Completed Phase 2 study, sponsored by Academic and Community Cancer Research United.
NCT03981614 is a Phase 2 study that has completed, run by Academic and Community Cancer Research United. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03981614, a Phase 2 study, has completed, sponsored by Academic and Community Cancer Research United.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.
Primary Outcome
Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be documented at each enrolling site with no central review planned. PFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.05. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced.
Interventions
- DRUG Palbociclib
- DRUG Binimetinib
- DRUG Trifluridine and Tipiracil Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2024-07-02 |
| Phase | Phase 2 |
What the finished NCT03981614 record still lists
NCT03981614 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Palbociclib is the first listed.
NCT03981614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03981614 about?
NCT03981614 is a clinical study titled "Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer". This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib m...
What is the current status of trial NCT03981614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2019-10-29. Estimated completion is 2024-07-02.
What interventions are being tested in trial NCT03981614?
The interventions under investigation include: Palbociclib (DRUG), Binimetinib (DRUG), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03981614?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03981614's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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