|Closed||Malignant Melanoma||Phase III||
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 960 mg orally twice daily or dacarbazine 1000mg/m2 intravenously every 3 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is 500-1000 individuals.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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