A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
Completed · Phase 1
Conditions studied: Malignant Melanoma, Neoplasms
In brief
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 with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).
Key facts
- Study ID
- NCT01844674
- Run by
- Hoffmann-La Roche
- People needed
- 18
- Starts
- 2013-09-02
- Expected to finish
- 2014-08-26
- Last updated by the study team
- 2017-03-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
- Pregnant or breastfeeding women
Where it is running
- Diablo Valley Oncology and Hematology — Pleasant Hill, California, United States
- Karmanos Cancer Center — Detroit, Michigan, United States
- Duke University Health Systems — Durham, North Carolina, United States
- Instituto Nacional do Cancer - INCA — Rio de Janeiro, Rio de Janeiro, Brazil
- Hospital de Caridade de Ijui; Oncologia — Ijuí, Rio Grande do Sul, Brazil
- CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo — Passo Fundo, Rio Grande do Sul, Brazil
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- CSSS champlain - Charles-Le Moyne — Greenfield Park, Quebec, Canada
- Bank of Cyprus Oncology Center — Nicosia, Cyprus
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Asan Medical Center. — Seoul, South Korea
Full record on ClinicalTrials.gov
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