A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)
This study has been completed.
Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01804140
First received: February 26, 2013
Last updated: September 1, 2016
Last verified: September 2016
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Purpose
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 |
|---|
|
Multiple Myeloma, Neoplasms |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by Genentech, Inc.:
Primary Outcome Measures:
- Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]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
| Enrollment: | 662 |
| Study Start Date: | December 2012 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804140
Please refer to this study by its ClinicalTrials.gov identifier: 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. |
More Information
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01804140 History of Changes |
| Other Study ID Numbers: | ML28560 |
| Study First Received: | February 26, 2013 |
| Results First Received: | June 16, 2015 |
| Last Updated: | September 1, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 27, 2016