At a glance
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A Phase I, Open-Label, Multicenter, 3-Period, Fixed-Sequence Study To Investigate The Effect Of Vemurafenib On The Pharmacokinetics Of A Single Dose Of Digoxin In Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
In Brief
A Phase 1 clinical trial evaluating Digoxin and Vemurafenib for Malignant Melanoma, Neoplasms. Completed, enrolled 29 participants across 13 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.
Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35.