A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

Launched by HOFFMANN-LA ROCHE · May 10, 2013

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Eligibility criteria

• Inclusion Criteria:
• • Adult patients, 18-70 years of age
• • Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have no acceptable standard treatment options
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• • Full recovery from any major surgery or significant traumatic injury at least 14 days prior to the first dose of study treatment
• • Adequate hematologic and end organ function
• • Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 effective methods of contraception as defined by protocol during the course of the study and for at least 6 months after completion of study treatment
• Exclusion Criteria:
• • Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
• • Prior anti-cancer therapy within 28 days (6 weeks for nitrosureas or mitocyn C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment Day 1
• • Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1
• • Experimental therapy within 4 weeks prior to first dose of study treatment Day 1
• • History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/=2 hypertension or unstable angina
• • Current Grade \>/=2 dyspnea or hypoxia or need for oxygen supplementation
• • History of myocardial infarction within 6 months prior to first dose of study treatment
• • Active central nervous system lesions (i.e. participants with radiographically unstable, symptomatic lesions)
• • History of bleeding or coagulation disorders
• • Allergy or hypersensitivity to vemurafenib or acenocoumarol formulations
• • History of malabsorption or other condition that would interfere with the enteral absorption of study treatment
• • Participants with VKORC1 mutations (1639G\→A, 1173C\→T) in either one allele (heterozygous)or two alleles (homozygous)
• • Participants with CYP2C9\*3 mutations in either one allele (heterozygous) or two alleles (homozygous)
• • History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection
• • Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness
• • Pregnant or lactating women