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

Genentech, Inc.662 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

662

Conditions

Multiple Myeloma, Neoplasms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Unnamed facility

Sedona, Arizona, United States

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type

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.

Time frame: Up to 1 year

Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples

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.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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