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. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01586195
First received: April 24, 2012
Last updated: August 4, 2014
Last verified: August 2014

April 24, 2012
August 4, 2014
October 2011
June 2016   (final data collection date for primary outcome measure)
Best objective response rate (BORR) according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01586195 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
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

This is an open-label, multicenter, single-agent, phase II study of continuous o ral Zelboraf (vemurafenib) in patients with locally-advanced, unresectable, stag e IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V 600E.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: Zelboraf (vemurafenib)
repeating oral dose
Experimental: Zelboraf (Vemurafenib) oral repeating dose
Intervention: Drug: Zelboraf (vemurafenib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Reference Study ID Number: ML27763 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States
 
NCT01586195
ML27763
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
August 2014

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