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.
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
21
sites
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