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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 146 participants.
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.
Interventions
- DRUG Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01378975
The ClinicalTrials.gov registry entry for NCT01378975 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 146 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 1 intervention - of which Vemurafenib is the first listed.
NCT01378975 reports 0 study locations.
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.
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