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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2015
End Date:February 2018
Contact:Jabed Seraj, MD., PhD
Email:seraj@taihopui.com

Use our guide to learn which trials are right for you!

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

Inclusion

1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer)

3. Has normal hepatic function, mild, moderate, or severe hepatic impairment

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, shunt in the liver 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
8
sites
Cleveland, Ohio 44195
Phone: 855-598-8259
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Baltimore, Maryland 21231
Phone: 855-598-8259
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02215
Phone: 855-598-8259
?
mi
from
Boston, MA
Click here to add this to my saved trials
Dallas, Texas 75246
Phone: 855-598-8259
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Duarte, California 91010
Phone: 855-598-8259
?
mi
from
Duarte, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15218
Phone: 855-598-8259
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Santa Monica, California 90404
Phone: 855-598-8259
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85259
Phone: 855-776-0015
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials