Spots Global Cancer Trial Database for Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies

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Trial Identification

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

Official Title: A Phase 1, Open-Label, Absolute Bioavailability Study of Vemurafenib in Patients With BRAF^V600 Mutation-Positive Malignancies

Study ID: NCT02441465

Conditions

Malignant Melanoma, Cancer

Interventions

Vemurafenib

14C-Labeled Vemurafenib

Study Description

Brief Summary: The purpose of this study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and following multiple oral doses of vemurafenib twice daily (BID) at steady state as well as to estimate the absolute bioavailability of multiple oral doses of vemurafenib BID at steady state in participants with BRAF\^V600 mutation-positive malignancies. The study has two periods: Period A and Period B. During Period A, participants will receive vemurafenib BID orally from Day 1 to Day 20 and during Period B, participants will receive single IV infusion of 14C-labeled vemurafenib along with vemurafenib BID oral dose.

Detailed Description: