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

• 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: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

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 Design

• 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

Groups and Cohorts

Group/Cohort
Cohort

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01804140
• Other Study ID Numbers: ML28560
• First Posted: March 5, 2013
• 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