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

Malignant Melanoma Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01519323
• Other study ID #: NO25390
• Secondary ID: 2011-000874-67
• Status: Recruiting
• Phase: Phase 1
• First received: January 16, 2012
• Last updated: February 1, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: NO25390 www.roche.com/about_roche/roc
• Phone: 888-662-6728 (U.S. Only)
• Email: global.rochegenentechtrials[@]roche.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• vemurafenib
Multiple doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Italy,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)/recommended dose		approximately 4 years	No
Secondary	Pharmacokinetics: Area under the concentration-time curve		Pre- and post-dose Days 1, 15 and 22 of Cycle 1, Day 1 in following Cycles	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No
Secondary	Best overall response rate (BORR; tumor assessments according to RECIST criteria)		approximately 4 years	No
Secondary	Clinical benefit rate (CBR)		approximately 4 years	No
Secondary	Progression-free survival (PFS)		approximately 4 years	No
Secondary	Overall survival (OS)		approximately 4 years	No