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

Completed

• Conditions: Multiple Myeloma, Neoplasms

• Registration Number: NCT01804140
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Results First Submitted: 2015-06-16
• Results First Submitted QC: 2015-07-29
• Results First Posted: 2015-07-31
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 662

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type	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.
Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples	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.