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Melanoma

Randomized Trial of RO5185426 vs Dacarbazine (NO25026-ROW)
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
Status Conditions Phase Study ID
Closed Malignant Melanoma Phase III NO25026-ROW
NCT01006980
Summary

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.


Investigator
Kim Margolin, M.D.
Location    
SCCA Melanoma Program 206-288-7370 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Last Updated
February 16, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.