Conditions: Malignant Melanoma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief summary:
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: RO5185426 intervention 2: RO5185426 intervention 3: RO5185426
Intervention descriptions: intervention 1: Single oral dose, fasted intervention 2: Single oral dose, with high fat meal intervention 3: Continuous administration, orally twice daily

Protocol document: