BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519323
First received: January 16, 2012
Last updated: September 22, 2014
Last verified: September 2014

January 16, 2012
September 22, 2014
January 2013
May 2016   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD)/recommended dose [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01519323 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre- and post-dose Days 1, 15 and 22 of Cycle 1, Day 1 in following Cycles ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Best overall response rate (BORR; tumor assessments according to RECIST criteria) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate (CBR) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
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 effi cacy tail extension will evaluate the maximum tolerated dose/recommended dose, t he safety and efficacy of vemurafenib (RO5185426) in pediatric patients (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresect able Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Patients will receive vemurafenib orally twice daily until disease progression or unacceptabl e toxicity occurs.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: vemurafenib
Multiple doses
Experimental: Single Arm
Intervention: Drug: vemurafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
27
May 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
No
Contact: Reference Study ID Number: NO25390 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Australia,   France,   Germany,   Israel,   Italy,   Poland,   Slovakia,   Spain,   United Kingdom
 
NCT01519323
NO25390, 2011-000874-67
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP