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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 675 participants.
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.
Interventions
- DRUG Vemurafenib
- DRUG Dacarbazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2010-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01006980
The ClinicalTrials.gov registry entry for NCT01006980 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 675 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vemurafenib is the first listed.
NCT01006980 reports 0 study locations.
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.
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