CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
Rifampin +1 moredrug
Likely dose
Rifampin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01765543
NCT01765543Phase 1Completed
CompareCT.gov

A Phase I, Open-Label, Multicenter, Three-Period, One-Sequence Study to Investigate the Effect of Rifampin on the Pharmacokinetics of a Single Oral Dose of 960 mg of Vemurafenib

Hoffmann-La Roche·interventional·Posted Jan 10, 2013·Updated Dec 15, 2016

In Brief

A Phase 1 clinical trial evaluating Rifampin and Vemurafenib for Malignant Melanoma, Neoplasms. Completed, enrolled 27 participants across 15 sites in 5 countries.

Detailed Summary

This open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the PK of vemurafenib in participants 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. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study GO28399 (NCT01739764).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma, Neoplasms
CountriesBrazil, Croatia, Egypt, South Africa, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2013
Enrollment StartJul 1, 2013
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.5 years ago

Interventions

Rifampindrug

Rifampin at a dose of 600 mg as capsules orally once daily will be administered from Days 8 through 23 (Periods B and C).

Vemurafenibdrug

Participants, after an overnight fast of at least 10 hours, will receive vemurafenib at a dose of 960 mg as film-coated tablets orally on Day 1 (Period A) and on Day 17 (Period C).