NCT01910181

A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma

A Phase I Open-Label, Multicenter, Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Vemurafenib in Chinese Patients With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy of vemurafenib in Chinese participants with BRAF V600 mutation-positive unresectable or metastatic melanoma. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until disease progression or unacceptable toxicity occurs.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Vemurafenib	Participants will receive vemurafenib at a dose of 960 mg twice daily orally.

Timeline

• Start date: 2013-08-17
• Primary completion: 2013-10-22
• Completion: 2018-04-20
• First posted: 2013-07-29
• Last updated: 2019-05-29
• Results posted: 2016-06-08

Locations

2 sites across 1 country: China