A Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

Status:	Completed
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	January 2010
End Date:	April 2015

BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Global Study on Progression-free and Overall Survival in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving RO5185426 or Dacarbazine

This randomized, open-label study will evaluate the efficacy, safety and tolerability of
RO5185426 as compared to dacarbazine in previously untreated patients with metastatic
melanoma. Patients will be randomized to receive either RO5185426 [RG7204; PLEXXIKON:
PLX4032] 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks.
Anticipated time on study treatment is until disease progression or unacceptable toxicity
occurs. Patients in the dacarbazine arm may cross over to RO5185426 treatment.

Inclusion Criteria:

- adult patients, >/=18 years of age

- metastatic melanoma, stage IIIC or IV (AJCC)

- treatment-naïve (no prior systemic anticancer therapy)

- positive for BRAF V600E mutation

- measurable disease by RECIST criteria

- negative pregnancy test and, for fertile men and women, effective contraception
during treatment and for 6 months after completion

Exclusion Criteria:

- active CNS metastases

- history of carcinomatous meningitis

- severe cardiovascular disease within 6 months prior to study drug administration

- previous malignancy within 5 years prior to study, except for basal or squamous cell
carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix

We found this trial at

sites

Clinical Trial Facility in New York New York

New York, New York 10032

from

New York, NY