A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 2, 2013

Primary Completion Date

August 26, 2014

Study Completion Date

August 26, 2014

Conditions
Malignant Melanoma, Neoplasms
Interventions
DRUG

Tizanidine

Participants will receive tizanidine as single oral doses, 2 milligrams (mg) on Day 1 and repeated on Day 22, each following an overnight fast \>/= 10 hours.

DRUG

Vemurafenib

Participants will receive vemurafenib as multiple oral doses, 960 mg twice daily on Days 2 to 22.

Trial Locations (12)

2006

Bank of Cyprus Oncology Center, Nicosia

27710

Duke University Health Systems, Durham

48201

Karmanos Cancer Center, Detroit

94523

Diablo Valley Oncology and Hematology, Pleasant Hill

20560-120

Instituto Nacional do Cancer - INCA, Rio de Janeiro

98700-000

Hospital de Caridade de Ijui; Oncologia, Ijuí

99010-260

CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo, Passo Fundo

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

J4V 2H1

CSSS champlain - Charles-Le Moyne, Greenfield Park

03722

Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

138-736

Asan Medical Center., Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01844674 - A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies | Biotech Hunter | Biotech Hunter