Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2015-06-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.
• Treatments: Pharmaceutical Solutions; Trifluridine

Criteria

Inclusion Criteria:

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

2. ECOG performance status of 0 or 1

3. Is able to take medications orally

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

5. 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 a medical condition that jeopardizes or impairs ability to collect representative excreta

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

6. Known sensitivity to TAS-102 or its components

7. Is a pregnant or lactating female

8. Refuses to use an adequate means of contraception (including male patients)

9. Is an occupationally exposed worker as defined by relevant ionizing radiation regulations

10. Has been exposed to 14C in the last 12 months