Clinical Trial VICCMD1286
Screening Protocol to Detect BRAF V600 Mutation Positive Patients for Enrollment into Clinical Research Studies of Vemurafenib
- Protocol No. VICCMD1286
- Open Date: 12/17/2012
- Staging: NA
- Age Group: Adults
- Scope: National
- Objective: The objective of this study is to identify patients who have solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma that harbor activating BRAF V600 mutations for potential enrollment into a vemurafenib clinical study (MD1188).
- Disease Sites: Breast; Head/Neck; Sarcoma; Gynecologic; Dermatologic; Prostate; Bladder; Kidney (Renal Cell); Ovarian; Pancreatic; Cervical; Esophageal; Colon; Rectal; Adrenocortical; Liver; Lung; Uterine; Small Cell; Multiple Myeloma; GIST; Gastric/Gastroesophageal; Neuroendocrine
- Therapies: None Specified
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- Secondary Protocol No: ML28560
The purpose of this screening protocol is to test tumor samples for a BRAF V600 mutation, which is one of the necessary eligibility criteria to enter the clinical trial titled MD1188. The purpose of the MD1188 trial is to test the safety and efficacy of the investigational drug called Vemurafenib (also known as RO5185426 or RG7204 or PLX4032) for the treatment of malignant tumors, other than metastatic melanoma or papillary thyroid cancer, which harbor a BRAF V600 mutation. Researchers have found that some malignant tumors have mutations (changes) of the BRAF gene. Genes are a specific part of DNA that contains information on hereditary characteristics such as hair color and eye color. The BRAF gene codes for a protein called BRAF, which is involved in sending signals in cells that can lead to cell growth. Certain mutations in the BRAF gene cause a change in the BRAF protein that can increase the growth and spread of cancer cells. Only patients whose tumors have the mutated BRAF gene may take part in the MD1188 trial. When first diagnosed with cancer, patients may have had a biopsy or removal of tissue that contained a sample of tumor. If a tumor sample is not already available and a patient decides to take part in this screening protocol, the study doctor might need to perform a biopsy or remove a part of the tumor according to local standard procedures which might include invasive/ surgical intervention. Patient participation in this screening protocol to analyze tumor samples for a BRAF V600 mutation is required for principle eligibility in the MD1188 trial. If a tumor sample tests negative for a BRAF V600 mutation, that patient may not enter into the MD1188 trial. The study doctor or treating doctor will discuss other treatment options with patients who do not qualify for the MD1188 trial.
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