A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)
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| ClinicalTrials.gov Identifier: NCT01804140 |
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Recruitment Status :
Completed
First Posted : March 5, 2013
Results First Posted : July 31, 2015
Last Update Posted : November 2, 2016
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Vemurafenib
U.S. FDA Resources
| Group/Cohort |
|---|
| Cohort |
Primary Outcome Measures :
- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01804140 History of Changes |
| Other Study ID Numbers: |
ML28560 |
| First Posted: | March 5, 2013 Key Record Dates |
| Results First Posted: | July 31, 2015 |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | November 2016 |
Additional relevant MeSH terms:
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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 Vemurafenib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |