Spots Global Cancer Trial Database for A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment

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Trial Identification

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

Conditions

Advanced Solid Tumors

Interventions

TAS-102

Study Description

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.