NCT02608034

A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

A Two-part, Phase I, Open-label, Multicenter, Two-period, One-sequence Study to Investigate the Effect of Itraconazole and Rifampin on the PK of Vemurafenib at Steady State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF where the participant has no acceptable standard treatment options.

Conditions

• Metastatic Melanoma, BRAF V600 Mutation Positive

Interventions

Type	Name	Description
DRUG	Itraconazole	Itraconazole will be administered as a 200 mg oral solution QD during Part 1 only for 20 consecutive days.
DRUG	Rifampin	Rifampin will be administered as a 600 mg oral solution QD during Part 2 only for 20 consecutive days.
DRUG	Vemurafenib	Vemurafenib will be administered in both Part 1 and Part 2 at a dose of 960 mg BID for at least 40 conseutive days.

Timeline

• Start date: 2016-05-26
• Primary completion: 2018-09-10
• Completion: 2018-09-10
• First posted: 2015-11-18
• Last updated: 2020-02-12

Locations

11 sites across 4 countries: United States, Israel, Russia, South Korea