Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:November 2015

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

A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of FTD and TPI

The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral
solution containing equivalent amounts FTD and TPI.

This is a Phase 1, open-label, randomized, 2-sequence, 3-period crossover study evaluating
the relative bioavailability of TAS-102 tablets compared to an oral solution in patients
with advanced solid tumors. This study will be conducted in 2 parts. The crossover
bioavailability part will be followed by an extension conducted with TAS-102 tablets only.

Inclusion Criteria:

1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy
exists

3. ECOG performance status of 0 or 1

4. Is able to take medications orally

5. Has adequate organ function (bone marrow, kidney and liver)

6. 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 Criteria:

1. Has had certain other recent treatment e.g. anticancer therapy, received
investigational agent, within the specified time frames prior to study drug
administration

2. Certain serious illnesses or medical condition(s)

3. Has had either partial or total gastrectomy

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

5. Known sensitivity to TAS-102 or its components

6. Is a pregnant or lactating female

7. Refuses to use an adequate means of contraception (including male patients)
We found this trial at
1
site
Scottsdale, Arizona 85259
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials