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

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01519323

First received: January 16, 2012

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2012

Last Updated Date

May 7, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

September 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01519323 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Malignant Melanoma

Intervention ^ICMJE

Drug: vemurafenib

Multiple doses

Study Arm (s)

Experimental: Single Arm

Intervention: Drug: vemurafenib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2016

Estimated Primary Completion Date

September 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: NO25390 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States, Australia, Germany, Italy, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01519323

Other Study ID Numbers ^ICMJE

NO25390, 2011-000874-67

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

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

To Top