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NCT01271803 · ClinicalTrials.gov registry record · Phase 1
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
A Phase 1 study of Malignant Melanoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 131
- Enrollment target
- 10
- Study locations
NCT01271803: Completed Phase 1 study of Malignant Melanoma, sponsored by Hoffmann-La Roche.
NCT01271803 is a Phase 1 study of Malignant Melanoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 131 participants, below the 179-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (27% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01271803, a Phase 1 study of Malignant Melanoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 131 participants
- Enrollment target
- 10
- Study locations
Study Summary
This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage \[DES\] and Cohort Expansion Stage \[CES\]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.
Primary Outcome
DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fe
Conditions Studied
Interventions
- DRUG Cobimetinib
- DRUG vemurafenib
Study Locations (10)
California
- UCLA Department of Medicine - Los Angeles
- University of California at San Francisco - San Francisco
- The Angeles Clinic and Research Institute, Santa Monica Office - Santa Monica
Colorado
- University of Colorado; Anschutz Cancer Pavilion - Aurora
Illinois
- University of Chicago - Chicago
Indiana
- Indiana University - Department of Medicine, Division of Gastroenterology/Hepatology - Indianapolis
Michigan
- Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building - Detroit
New York
- New York University Medical Center - New York
Tennessee
- Vanderbilt University Medical Center - Nashville
Victoria
- Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2011-02-17 |
| Est. Completion | 2017-12-12 |
| Phase | Phase 1 |
What the finished NCT01271803 record still lists
NCT01271803 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Cobimetinib is the first listed.
NCT01271803 lists 10 locations in 8 states (California, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT01271803 about?
NCT01271803 is a clinical study titled "A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma". This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced...
What is the current status of trial NCT01271803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2011-02-17. Estimated completion is 2017-12-12.
What conditions does trial NCT01271803 study?
This clinical trial studies the following conditions: Malignant Melanoma.
What interventions are being tested in trial NCT01271803?
The interventions under investigation include: Cobimetinib (DRUG), vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01271803?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01271803 being conducted?
This trial has 10 study locations across California, Colorado, Illinois, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01271803's enrollment target sits among peer trials
131 8th of 28 higher than 21 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Melanoma 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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