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NCT00949702 · ClinicalTrials.gov registry record · Phase 2
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT00949702: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00949702 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00949702, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study Summary
This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \<100 patients.
Primary Outcome
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum
Interventions
- DRUG vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2009-09-30 |
| Est. Completion | 2014-06-03 |
| Phase | Phase 2 |
What the finished NCT00949702 record still lists
NCT00949702 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which vemurafenib is the first listed.
NCT00949702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00949702 about?
NCT00949702 is a clinical study titled "A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma". This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdr...
What is the current status of trial NCT00949702?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2009-09-30. Estimated completion is 2014-06-03.
What interventions are being tested in trial NCT00949702?
The interventions under investigation include: vemurafenib (DRUG).
Who is sponsoring clinical trial NCT00949702?
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 NCT00949702's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 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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