At a glance
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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
In Brief
A Phase 1 clinical trial evaluating RO5185426 for Malignant Melanoma. Completed, enrolled 52 participants across 13 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
dosage b) orally twice daily, days 1-15 (morning dose)
dosage c) orally twice daily, days 1-15 (morning dose)
dosage d) orally twice daily, days 1-15 (morning dose)
960 mg orally twice daily, from day 22 onward
dosage a) orally twice daily, days 1-15 (morning dose)