At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 132 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.
An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating vemurafenib for Malignant Melanoma. Completed, enrolled 132 participants across 15 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartSep 2009
Primary CompletionSep 2010
Study CompletionJun 2014
TodayJul 2026
First PostedJul 30, 2009
Enrollment StartSep 30, 2009
Primary CompletionSep 27, 2010
Study CompletionJun 3, 2014
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 16.9 years ago
Interventions
vemurafenibdrug
960 mg b.i.d. continuous oral dosing