A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment



Status:Recruiting
Conditions:Cancer, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:January 2015
End Date:July 2019
Contact:Robert Winkler, MD
Email:rwinkler@taihooncology.com
Phone:609-750-5300

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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 Renal Impairment

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with
advanced solid tumors and varying degrees of renal impairment.

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.

Inclusion

1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer)

3. Has normal renal function, mild, moderate, or severe renal impairment and is not on
dialysis

4. ECOG performance status of ≤2

5. Is able to take medications orally

6. Has adequate organ function

7. 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

1. Certain serious illnesses or medical condition(s)

2. 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

3. Has received TAS-102

4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any
prior therapies

5. Is a pregnant or lactating female
We found this trial at
11
sites
1395 Center Drive
Gainesville, Florida 32610
Phone: 855-598-8259
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Baltimore, Maryland 21231
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Boston, Massachusetts 02215
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68 Křižíkova
Brno, 612 00
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Brno,
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Cleveland, Ohio 44195
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Cleveland, Ohio 44195
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Dallas, Texas 75246
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Duarte, California 91010
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Phoenix, Arizona 85021
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Pittsburgh, Pennsylvania 15218
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Santa Monica, California 90404
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Santa Monica, CA
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