BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | July 2016 |
| Contact: | Reference Study ID Number: NO25390 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. Only) |
An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of RO5185426 in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations Mutations
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 (RO5185426) in pediatric patients (aged 12 through 17) with newly diagnosed
or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring
BRAFV600 mutations. Patients will receive vemurafenib orally twice daily until disease
progression or unacceptable toxicity occurs.
extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy
of vemurafenib (RO5185426) in pediatric patients (aged 12 through 17) with newly diagnosed
or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring
BRAFV600 mutations. Patients will receive vemurafenib orally twice daily until disease
progression or unacceptable toxicity occurs.
Inclusion Criteria:
- Pediatric patients, 12 to 17 years of age inclusive
- Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV
(AJCC) melanoma
- Positive BRAF mutation result (Cobas 4800 BRAF V600 Mutation Test)
- Measurable disease according to RECIST criteria
- Performance status: Karnofsky (for patients >/= 16 years of age) or Lansky (for
patients < 16 years of age) score of >/= 60
- Adequate bone marrow, liver and renal function
- Patients must have fully recovered from the acute toxic effects of all prior therapy
prior to first administration of study drug
Exclusion Criteria:
- 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 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 HIV positivity or AIDS-related illness, active hepatitis B virus, or active
hepatitis C virus
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