Conditions: Malignant Melanoma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: RO5185426 intervention 2: RO5185426 intervention 3: RO5185426 intervention 4: RO5185426 intervention 5: RO5185426
Intervention descriptions: intervention 1: dosage b) orally twice daily, days 1-15 (morning dose) intervention 2: dosage c) orally twice daily, days 1-15 (morning dose) intervention 3: dosage d) orally twice daily, days 1-15 (morning dose) intervention 4: 960 mg orally twice daily, from day 22 onward intervention 5: dosage a) orally twice daily, days 1-15 (morning dose)

Protocol document: