Clareo Health | A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults 18 to 70 years of age, inclusive
Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, as determined by Cobas 4800 BRAFV600 Mutation Test or a DNA sequencing method
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Life expectancy greater than or equal to (\>/=) 12 weeks
Participant has not consumed tobacco or nicotine-containing products for 42 days prior to first dose of study drug, and must agree to refrain from such products while on study
Adequate hematologic, renal and liver function
You may not be if
Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
History of or current clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/= 2 hypertension or unstable angina
Current dyspnea at rest due to complications of advanced malignancy or any requirement for supplemental oxygen
Active central nervous system lesions (participants with radiographically unstable, symptomatic lesions)
Participants with CYP1A2 gene mutation (-3113G-\>A), either in one or two alleles
Allergy or hypersensitivity to vemurafenib or tizanidine formulations
Current severe uncontrolled systemic disease
Inability or unwillingness to swallow pills
History of malabsorption or other condition that would interfere with enteral absorption of study treatment
History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or human immunodeficiency (HIV) infection requiring antiretroviral treatment, acquired immune deficiency syndrome (AIDS)-related illness, or active hepatitis B or C
