Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

Key facts

Study ID

NCT01867866

Run by

Taiho Oncology, Inc.

People needed

44

Starts

2013-05-01

Expected to finish

2016-06-01

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has provided written informed consent
• Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
• ECOG performance status of 0 or 1
• Is able to take medications orally
• Has adequate organ function (bone marrow, kidney and liver)
• 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.

You may not qualify if…

• Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
• Certain serious illnesses or medical condition(s)
• Has had either partial or total gastrectomy
• Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
• Known sensitivity to TAS-102 or its components
• Is a pregnant or lactating female
• Refuses to use an adequate means of contraception (including male patients)

Where it is running

• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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