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

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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
21
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964
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Seattle, WA
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Atlanta, GA
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Boston, MA
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Brisbane,
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Chapel Hill, NC
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Detroit, MI
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Indianapolis, IN
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13
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Los Angeles, CA
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Nashville, TN
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Portland, OR
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San Francisco, CA
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26
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Santa Monica, CA
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St Louis, MO
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427
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Tucson, AZ
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