Conditions: Malignant Melanoma, Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

Brief summary:
This open-label, multi-center, three-period, one sequence study will investigate the effect of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive multiple doses of vemurafenib in Periods B and C and a single dose of digoxin in Periods A and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 36 days.

Detailed description:

Arms:
arm 1: Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg tablet orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.

Interventions: intervention 1: Digoxin intervention 2: Vemurafenib
Intervention descriptions: intervention 1: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29. intervention 2: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35.

Protocol document: