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Brief Title: A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
Official Title: A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAS-102 in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment.
Study ID: NCT02301104
Brief Summary: Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.
Detailed Description: This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of hepatic impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Scottsdale, Arizona, United States
Duarte Clinical Site, Duarte, California, United States
Santa Monica Clinical Site, Santa Monica, California, United States
Baltimore Clinical Site, Baltimore, Maryland, United States
Boston Clinical Site, Boston, Massachusetts, United States
Cleveland Clinical Site, Cleveland, Ohio, United States
Pittsburgh Clinical Site, Pittsburgh, Pennsylvania, United States
Dallas Clinical Site, Dallas, Texas, United States