Overview

This trial is active, not recruiting.

Condition malignant melanoma
Treatments ro5185426, dacarbazine
Phase phase 3
Target BRAF
Sponsor Hoffmann-La Roche
Start date January 2010
End date December 2010
Trial size 677 participants
Trial identifier NCT01006980, 2009-012293-12, NO25026

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 [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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ro5185426
960 mg orally twice daily
(Active Comparator)
dacarbazine
1000 mg/m2 iv every 3 weeks

Primary Outcomes

Measure
Overall Survival
time frame: From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).
Progression-free Survival
time frame: From randomization (initiated January 2010) to December 30 2010.

Secondary Outcomes

Measure
Participants With a Best Overall Response (BOR) of Complete Response or Partial Response
time frame: From randomization (initiated January 2010) until December 30, 2010
Duration of Response
time frame: From randomization (initiated in January 2010) until December 30, 2010.
Time to Confirmed Response
time frame: From randomization (initiated January 2010) until December 30, 2010.
Time to Treatment Failure
time frame: approximately 3 years
Number of Participants With Adverse Events (AEs)
time frame: From randomization (initiated January 2010) until December 30, 2010.
Pre and Post-dose Plasma Vemurafenib Concentration by Study Day
time frame: Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.