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NCT01006980 · ClinicalTrials.gov registry record · Phase 3
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 675
- Enrollment target
NCT01006980: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01006980 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 675 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01006980, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 675 participants
- Enrollment target
Study Summary
This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.
Primary Outcome
An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.
Interventions
- DRUG Vemurafenib
- DRUG Dacarbazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2010-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01006980 record still lists
NCT01006980 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Vemurafenib is the first listed.
NCT01006980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01006980 about?
NCT01006980 is a clinical study titled "A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)". This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m...
What is the current status of trial NCT01006980?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2010-01. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01006980?
The interventions under investigation include: Vemurafenib (DRUG), Dacarbazine (DRUG).
Who is sponsoring clinical trial NCT01006980?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01006980's enrollment target sits among peer trials
675 538th of 2000 higher than 1,458 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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