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NCT03224767 · ClinicalTrials.gov registry record · Phase 2
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
A Phase 2 study of BRAF V600E Mutation Present and Papillary Craniopharyngioma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT03224767: Active Phase 2 study of BRAF V600E Mutation Present and Papillary Craniopharyngioma, sponsored by Alliance for Clinical Trials in Oncology.
NCT03224767 is a Phase 2 study of BRAF V600E Mutation Present and Papillary Craniopharyngioma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03224767, a Phase 2 study of BRAF V600E Mutation Present and Papillary Craniopharyngioma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Defined as the number of responses achieved during treatment with BRAF and MEK inhibitors divided by the total number of evaluable patients and assessed by contrast-enhanced magnetic resonance imaging or computed tomography. Point estimates will be generated for response rates within each cohort with corresponding 95% binomial confidence intervals. Simon's two-stage design with one interim analysis for futility will be applied to evaluate response rate within each cohort.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Vemurafenib
- DRUG Cobimetinib
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Eden Hospital Medical Center - Castro Valley
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Memorial Medical Center - Modesto
- Palo Alto Medical Foundation-Camino Division - Mountain View
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Palo Alto Medical Foundation Health Care - Palo Alto
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Sutter Roseville Medical Center - Roseville
- Sutter Medical Center Sacramento - Sacramento
- California Pacific Medical Center-Pacific Campus - San Francisco
- Palo Alto Medical Foundation-Sunnyvale - Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville - Vacaville
- Sutter Solano Medical Center/Cancer Center - Vallejo
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-01-05 |
| Est. Completion | 2028-08-01 |
| Phase | Phase 2 |
What the registry record for NCT03224767 still lists
NCT03224767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with BRAF V600E Mutation Present appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03224767 names 20 study sites across 3 states, led by California, Connecticut, Alabama.
Frequently Asked Questions
What is clinical trial NCT03224767 about?
NCT03224767 is a clinical study titled "Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma". This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT03224767?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2018-01-05. Estimated completion is 2028-08-01.
What conditions does trial NCT03224767 study?
This clinical trial studies the following conditions: BRAF V600E Mutation Present, Papillary Craniopharyngioma.
What interventions are being tested in trial NCT03224767?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Vemurafenib (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT03224767?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03224767 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03224767's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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