Status:
COMPLETED
A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma, Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
September 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01844674
Start Date
September 2 2013
End Date
August 26 2014
Last Update
March 20 2017
Active Locations (12)
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1
Diablo Valley Oncology and Hematology
Pleasant Hill, California, United States, 94523
2
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
3
Duke University Health Systems
Durham, North Carolina, United States, 27710
4
Instituto Nacional do Cancer - INCA
Rio de Janeiro, Rio de Janeiro, Brazil, 20560-120