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

NCT01804140 | Completed Results

• 1 other identifier: ML28560
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 20

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.

Conditions

Multiple Myeloma, Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 1 year

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (20)

Unknown Facility

Sedona, Arizona, 86336, United States

Location

Unknown Facility

Tucson, Arizona, 85704, United States

Location

Unknown Facility

Burbank, California, 91505, United States

Location

Unknown Facility

Rancho Cucamonga, California, 91730, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Ocala, Florida, 34471, United States

Location

Unknown Facility

Woodbury, Minnesota, 55125, United States

Location

Unknown Facility

Columbia, Missouri, 65201, United States

Location

Unknown Facility

Las Vegas, Nevada, 89169, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Amarillo, Texas, 79106, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

Dallas, Texas, 75237, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Denton, Texas, 76210, United States

Location

Unknown Facility

McAllen, Texas, 78503, United States

Location

Unknown Facility

Tyler, Texas, 75702, United States

Location

Unknown Facility

Spokane, Washington, 99204, United States

Location

Unknown Facility

Yakima, Washington, 98902, United States

Location

Biospecimen

Retention: NONE RETAINED

Formalin-fixed paraffin-embedded (FFPE) tumor samples

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 5, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 2, 2016
• Results First Posted: July 31, 2015

Record last verified: 2016-11

Locations

US (20)