Kidney Cancer Clinical Trial
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
Summary
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.
Full 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 renal 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.
Eligibility Criteria
Inclusion
Has provided written informed consent
Has advanced solid tumors (excluding breast cancer)
Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis
ECOG performance status of ≤2
Is able to take medications orally
Has adequate organ function
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion
Certain serious illnesses or medical condition(s)
Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
Has received TAS-102
Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
Is a pregnant or lactating female
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There are 12 Locations for this study
Phoenix Arizona, 85054, United States
Duarte California, 91010, United States
Santa Monica California, 90095, United States
Gainesville Florida, 32610, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75246, United States
Brno , , Czechia
Praha , , Czechia
Belgrade , 11080, Serbia
Sremska Kamenica , 21204, Serbia
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