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.
Verified April 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: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Drug: vemurafenib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD)/recommended dose [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 27
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: vemurafenib
Multiple doses

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519323

Contacts
Contact: Reference Study ID Number: NO25390 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 25 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519323     History of Changes
Other Study ID Numbers: NO25390, 2011-000874-67
Study First Received: January 16, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 15, 2014