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NCT01519323 · ClinicalTrials.gov registry record · Phase 1
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01519323 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 6 participants.
The verdict
NCT01519323, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.
Interventions
- DRUG vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01519323
The ClinicalTrials.gov registry entry for NCT01519323 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 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.
NCT01519323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01519323 about?
NCT01519323 is a clinical study titled "BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations". This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgicall...
What is the current status of trial NCT01519323?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-01. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01519323?
The interventions under investigation include: vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01519323?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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