Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

This study is currently recruiting participants.

Verified December 2012 by Genentech

Sponsor:

Information provided by (Responsible Party):

Genentech

ClinicalTrials.gov Identifier:

NCT01586195

First received: April 24, 2012

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2012

Last Updated Date

December 4, 2012

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Best objective response rate (BORR) according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01586195 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to response according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Duration of response according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Progression-free survival (PFS) according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Overall survival according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 18 months ] [ 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

Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

Official Title ^ICMJE

An Open-Label, Multicenter, Phase II Study Of Continuous Oral Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

Brief Summary

This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in patients with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

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: Zelboraf (vemurafenib)

repeating oral dose

Study Arm (s)

Experimental: Zelboraf (Vemurafenib) oral repeating dose

Intervention: Drug: Zelboraf (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

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 2
Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E
Measurable disease (as defined by RECIST, v1.1)
Adequate recovery from most recent systemic or local treatment for cancer
Adequate organ function
Women of childbearing potential and male partners of women of childbearing potential: agreement to use prescribed contraception.
Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of vemurafenib; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib

Exclusion Criteria:

Invasive malignancy other than melanoma at the time of enrollment and within 2 years prior
Pregnant or breast-feeding
Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, including participation in an experimental drug study)
Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
Ongoing cardiac dysrhythmia >/= Grade 2

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML27763 www.roche.com/about_roche/roche_worldwide.htm

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

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01586195

Other Study ID Numbers ^ICMJE

ML27763

Has Data Monitoring Committee

Not Provided

Responsible Party

Genentech

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Genentech

Information Provided By

Genentech

Verification Date

December 2012

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

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