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



Status:Completed
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2012
End Date:September 2013

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Screening Protocol to Detect BRAF V600 Mutation-Positive Patients for Enrollment Into Clinical Research Studies of Vemurafenib

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.


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
We found this trial at
18
sites
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Columbia, MO
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Amarillo, TX
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Austin, TX
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Burbank, CA
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Dallas, TX
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Denton, TX
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Denver, CO
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Las Vegas, NV
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McAllen, TX
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Nashville, TN
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Ocala, FL
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Rancho Cucamonga, California 91730
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Rancho Cucamonga, CA
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Sedona, AZ
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Spokane, WA
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Tucson, AZ
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Tyler, TX
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from
Woodbury, MN
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Yakima, WA
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