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A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)

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ClinicalTrials.gov Identifier: NCT01804140
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : July 31, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as defined by this screening protocol will have potential access to the separate vemurafenib protocol MO28072.

Condition or disease
Multiple Myeloma, Neoplasms

Study Type : Observational
Actual Enrollment : 662 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib
Study Start Date : December 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Vemurafenib
U.S. FDA Resources

Group/Cohort
Cohort



Primary Outcome Measures :
  1. Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type [ Time Frame: Up to 1 year ]
    Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.

  2. Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples [ Time Frame: Up to 1 year ]
    FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.


Biospecimen Retention:   None Retained
Formalin-fixed paraffin-embedded (FFPE) tumor samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma
Criteria

Inclusion Criteria:

  • Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
  • Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Uncontrolled concurrent malignancy
  • Active or untreated CNS metastases
  • History of known carcinomatous meningitis
  • Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)
  • Uncontrolled, severe medical illness or condition as defined in protocol MO28072

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804140


Locations
United States, Arizona
Sedona, Arizona, United States, 86336
Tucson, Arizona, United States, 85704
United States, California
Burbank, California, United States, 91505
Rancho Cucamonga, California, United States, 91730
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Ocala, Florida, United States, 34471
United States, Minnesota
Woodbury, Minnesota, United States, 55125
United States, Missouri
Columbia, Missouri, United States, 65201
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Amarillo, Texas, United States, 79106
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75237
Dallas, Texas, United States, 75246
Denton, Texas, United States, 76210
McAllen, Texas, United States, 78503
Tyler, Texas, United States, 75702
United States, Washington
Spokane, Washington, United States, 99204
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01804140     History of Changes
Other Study ID Numbers: ML28560
First Posted: March 5, 2013    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vemurafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action