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Trial record 1 of 1 for:    NCT01586195
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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 November 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01586195
First received: April 24, 2012
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Drug: Zelboraf (vemurafenib)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zelboraf (Vemurafenib) oral repeating dose Drug: Zelboraf (vemurafenib)
repeating oral dose

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586195

Contacts
Contact: Reference Study ID Number: ML27763 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Arizona
Recruiting
Tucson, Arizona, United States, 85724
United States, California
Active, not recruiting
La Jolla, California, United States, 92093
Recruiting
Los Angeles, California, United States, 90095
Recruiting
Santa Monica, California, United States, 90025
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Active, not recruiting
Tampa, Florida, United States, 33612-9497
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30308
United States, Illinois
Recruiting
Park Ridge, Illinois, United States, 60068
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
United States, New Jersey
Active, not recruiting
Morristown, New Jersey, United States, 07960
United States, New York
Recruiting
New York, New York, United States, 10032
United States, Ohio
Active, not recruiting
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Recruiting
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01586195     History of Changes
Other Study ID Numbers: ML27763
Study First Received: April 24, 2012
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 24, 2014