A Phase I, Randomized, Open-label, Multi-center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients
This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204; PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is <100 patients.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : RO5185426
Phase: Phase 1
Ages Eligible For Study:
- adult patients, >/=18 years of age - histologically confirmed metastatic melanoma, stage IIIc or IV (AJCC) - failure of at least one prior standard of care regimen - positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay) - ECOG performance status 0 or 1 - adequate hematologic, renal and liver function