Clinical Trials /

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

NCT01519323

Description:

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 participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.

Related Conditions:
  • Melanoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV <span class="go-doc-concept go-doc-disease">Melanoma</span> Harboring BRAFV600 <span class="go-doc-concept go-doc-keyword">Mutations</span>

Title

  • Brief Title: BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
  • 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
  • Clinical Trial IDs

    NCT ID: NCT01519323

    ORG ID: NO25390

    NCI ID: 2011-000874-67

    Trial Conditions

    Malignant Melanoma

    Trial Interventions

    Drug Synonyms Arms
    vemurafenib Single Arm

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Single Arm Experimental vemurafenib

    Eligibility 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

    Minimum Eligible Age: 12 Years

    Maximum Eligible Age: 17 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum tolerated dose (MTD)/recommended dose

    Secondary Outcome Measures

    Pharmacokinetics: Area under the concentration-time curve

    Safety: Incidence of adverse events

    Best overall response rate (BORR; tumor assessments according to RECIST criteria)

    Clinical benefit rate (CBR)

    Progression-free survival (PFS)

    Overall survival (OS)

    Trial Keywords