Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies

This is an interventional basic science trial for Malignant Melanoma, Cancer Read More

Inclusion Criteria:

• Participants with either unresectable or metastatic melanoma positive for the BRAF^V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, and for whom vemurafenib is an accepted standard of care or where there is no other generally accepted standard of care
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Life expectancy greater than or equal to (>/=) 12 weeks
• Full recovery from the effects of any major surgery or significant traumatic injury within 14 days from the first dose of study drug
• Adequate hematologic and end organ function as defined by laboratory results obtained within 2 weeks prior to administration of study drug on Day 1
• Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use two effective methods of contraception during the study and at least 6 months after completion of the study drug
• Negative serum pregnancy test results within 7 days prior to Day 1 in women of childbearing potential
• Absence of any psychological, familial, or sociological condition, or geographical constraints that could potentially hamper compliance with the study protocol and follow-up schedule

Exclusion Criteria:

• Prior anti-cancer therapy before the administration of study drug on Day 1
• Invasive malignancy other than BRAF mutant melanoma or other qualifying malignant tumor with BRAF^V600 mutation within the past 5 years
• History of clinically significant cardiac or pulmonary dysfunction
• Active central nervous system lesions
• Current, severe, uncontrolled systemic disease
• Inability or unwillingness to swallow tablets
• History of malabsorption, stomach or intestinal surgery/resection, or other condition that would potentially alter absorption and/or excretion of orally administered drugs
• History of clinically significant liver disease
• Active autoimmune disease
• Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
• Pregnancy, lactation, or breastfeeding
• Need to take a concomitant medication, dietary supplement, or food that is prohibited during the study
• Known allergy or sensitivity to components of the vemurafenib formulation
• Active, uncontrolled or chronic infection requiring chronic suppressive antibiotics
• Use of any prescription medications/products, that are known to be strong cytochrome P450 (CYP)3A4 inhibitors or inducers within 2 weeks prior to Day 1
• Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 30 days prior to Day 1 or within 5 times the elimination half-life of the respective drug (whichever is shorter)
• Participation in a trial involving administration of 14 C-radiolabeled compound(s) within 6 months prior to Day 1
• Poor peripheral venous access
• Any other acute or chronic condition that, in the opinion of the investigator, could limit the participant's ability to complete and/or participate in this clinical study