At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 46 enrolled
Drug / intervention
Vemurafenibdrug
Likely dose
Vemurafenib 960 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Open-Label, Multicenter, Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Vemurafenib in Chinese Patients With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
In Brief
A Phase 1 clinical trial evaluating Vemurafenib for Malignant Melanoma. Completed, enrolled 46 participants across 2 sites.
Detailed Summary
This open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy of vemurafenib in Chinese participants with BRAF V600 mutation-positive unresectable or metastatic melanoma. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until disease progression or unacceptable toxicity occurs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartAug 2013
Primary CompletionOct 2013
Study CompletionApr 2018
TodayJul 2026
First PostedJul 29, 2013
Enrollment StartAug 17, 2013
Primary CompletionOct 22, 2013
Study CompletionApr 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.9 years ago
Interventions
Vemurafenibdrug
Participants will receive vemurafenib at a dose of 960 mg twice daily orally.