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NCT01378975 · ClinicalTrials.gov registry record · Phase 2
A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
NCT01378975: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01378975 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 146 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378975, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
Study Summary
This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors\]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Primary Outcome
BORR assessed by IRC is defined as percentage of participants who were responders \[with best overall response (BOR) documented as confirmed complete response (CR) or partial response (PR)\]. The RECIST v1.1 criteria modified for independent review of body and brain lesions was based on current radiology practices. The modifications to RECIST v1.1 included allowing target lesions in the brain to be \>=5 mm by contrast-enhanced magnetic resonance imaging scan (in traditional RECIST v1.1 this is \
Interventions
- DRUG Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01378975 record still lists
NCT01378975 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 1 intervention - of which Vemurafenib is the first listed.
NCT01378975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378975 about?
NCT01378975 is a clinical study titled "A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases". This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral ...
What is the current status of trial NCT01378975?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2011-07. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01378975?
The interventions under investigation include: Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01378975?
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 NCT01378975's enrollment target sits among peer trials
146 496th of 2000 higher than 1,503 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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