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Clinical Trial VICCMD1188

Title

An Open-Label, Phase II Study of Vemurafenib in Patients with BRAF V600 Mutation-Positive Cancers

Principal Investigator(s)

Igor Puzanov

Details

  • Protocol No. VICCMD1188
  • Open Date: 06/08/2012
  • Staging: Phase II
  • Age Group: Adults
  • Scope: International
  • Objective: To evaluate the efficacy of vemurafenib in patients with cancers harboring BRAF V600 mutations as response rate (RR) at Week 8 determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1) or International Myeloma Working Group (IMWG) uniform response criteria and to identify tumor types for further development
  • 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: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Cetuximab; Cetuximab (Erbitux); PLX4032; RO5185426 (Vemurafenib); Vemurafenib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01524978
  • Secondary Protocol No: MO28072

Description

Previous studies have shown that treatment with vemurafenib can help patients with a specific type of metastatic melanoma (skin cancer that has spread to other parts of the body) that is caused by a problem (a mutation) in a gene called BRAF. Vemurafenib is approved in the USA and Switzerland for metastatic melanoma. It is being studied now for treating other kinds of tumors that have the BRAF gene. Patients are invited to take part in this study if they have one of the following types of cancer which can be caused by a problem in the BRAF gene: non-small cell lung carcinoma, ovarian cancer, colorectal cancer, breast cancer, prostate cancer, multiple myeloma (cancer of the plasma cells in bone marrow), cholangiocarcinoma (cancer of the biliary tract), or other kinds of solid tumors that have the same problem in the BRAF gene. Patients will be screened to find out if their tumors have the mutated BRAF gene. If a patient's tumor has the mutated BRAF gene, and if the patient meets the other eligibility requirements, the patient will be able to enroll in the study and take the study drug, vemurafenib.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Adult patients, >/=18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Must have recovered from all side effects of their most recent systemic or local treatment
• Adequate hematological, renal and liver function
For solid tumors only:
• Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist
• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
For multiple myeloma only:
• Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation
• Patients must have received at least one prior systemic therapy for the treatment of multiple myeloma
• Patients treated with local radiotherapy
• Patients must have relapsed and/or refractory multiple myeloma with measurable disease
Exclusion Criteria:
• Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
• Uncontrolled concurrent malignancy
• For patients with multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
• Active or untreated CNS metastases
• History of or known carcinomatous meningitis
• Concurrent administration of any anti-cancer therapies other than those administered in this study
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study