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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 has been terminated.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: April 24, 2012
Last updated: May 4, 2016
Last verified: May 2016
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.

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

Study Type: Interventional
Study Design: 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 ]

Secondary Outcome Measures:
  • Time to response according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ]
  • Duration of response according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ]
  • Progression-free survival (PFS) according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ]
  • Overall survival according to RECIST, v1.1 guidelines [ Time Frame: approximately 18 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 18 months ]

Enrollment: 31
Study Start Date: October 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zelboraf (Vemurafenib) oral repeating dose Drug: Zelboraf (vemurafenib)
repeating oral dose


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01586195

United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90095
Santa Monica, California, United States, 90025
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Illinois
Park Ridge, Illinois, United States, 60068
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New Jersey
Morristown, New Jersey, United States, 07960
United States, New York
New York, New York, United States, 10032
United States, Ohio
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01586195     History of Changes
Other Study ID Numbers: ML27763
Study First Received: April 24, 2012
Last Updated: May 4, 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on May 23, 2017