Status:
TERMINATED
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
Brief Summary
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (R...
Eligibility Criteria
Inclusion
- Pediatric participants, 12 to 17 years of age inclusive
- Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV (AJCC) melanoma
- Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation Test)
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Performance status: Karnofsky (for participants \>/= 16 years of age) or Lansky (for participants \< 16 years of age) score of \>/= 60
- Adequate bone marrow, liver and renal function
- Participants must have fully recovered from the acute toxic effects of all prior therapy prior to first administration of study drug
Exclusion
- Active or untreated central nervous system (CNS) lesions
- History of or known spinal cord compression or carcinomatous meningitis
- Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
- Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ, and carcinoma in-situ of the cervix
- Previous treatment with selective/specific BRAF or Methyl Ethyl Ketone (MEK) inhibitor (previous treatment with sorafenib is allowed)
- Any previous treatment with study drug (RO5185426) or participation in a clinical trial that includes RO5185426
- Pregnant or lactating females
- Known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS)-related illness, active hepatitis B virus, or active hepatitis C virus
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01519323
Start Date
January 1 2013
End Date
December 1 2015
Last Update
October 10 2016
Active Locations (26)
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1
Los Angeles, California, United States, 90027
2
Aurora, Colorado, United States, 80045
3
Saint Petersburgh, Florida, United States, 33701
4
Bethesda, Maryland, United States, 20892