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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sedona | Arizona | 86336 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Confirmed Solid Tumors or Multiple Myeloma | Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Formalin-fixed paraffin-embedded (FFPE) tumor samples
| Tucson |
| Arizona |
| 85704 |
| United States |
| Burbank | California | 91505 | United States |
| Rancho Cucamonga | California | 91730 | United States |
| Denver | Colorado | 80218 | United States |
| Ocala | Florida | 34471 | United States |
| Woodbury | Minnesota | 55125 | United States |
| Columbia | Missouri | 65201 | United States |
| Las Vegas | Nevada | 89169 | United States |
| Nashville | Tennessee | 37232 | United States |
| Amarillo | Texas | 79106 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75231 | United States |
| Dallas | Texas | 75237 | United States |
| Dallas | Texas | 75246 | United States |
| Denton | Texas | 76210 | United States |
| McAllen | Texas | 78503 | United States |
| Tyler | Texas | 75702 | United States |
| Spokane | Washington | 99204 | United States |
| Yakima | Washington | 98902 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Confirmed Solid Tumors or Multiple Myeloma | Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1 year |
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| Primary | 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. | All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. | Posted | Number | participants | Up to 1 year |
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All adverse events that occurred up to 28 days after the biopsy was performed or those adverse events that the physician considered to have causal relationship to the biopsy performed were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Confirmed Solid Tumors or Multiple Myeloma | Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards. | 0 | 548 | 0 | 548 |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| Ovarian cancer (n=66) |
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| Prostate cancer (n=21) |
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| Multiple myeloma (n=31) |
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| Biliary tract cancer (n=16) |
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| Other cancer (n=190) |
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| Overall (n=540) |
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