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

Taiho Pharma

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: TAS-102 tablets; Drug: TAS-102 with a light tracer dose of [14C]FTD; Drug: TAS-102 with a light tracer dose of [14C] TPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02031055

TPU-TAS-102-108

Details and patient eligibility

About

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.

Full description

This is a Phase 1, open-label study evaluating 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. The study will be conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the mass balance part, patients will receive continued treatment with TAS-102 during the study extension part.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

TAS-102 with light tracer dose of [14C]FTD

Experimental group

Treatment:

Drug: TAS-102 with a light tracer dose of [14C]FTD

Drug: TAS-102 tablets

TAS-102 with light tracer dose of [14C]TPI

Experimental group

Treatment:

Drug: TAS-102 with a light tracer dose of [14C] TPI

Drug: TAS-102 tablets