Clinical trial · Interventional
Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
A Phase 1, Open-label Study to Evaluate the Mass Balance of Orally Administered FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
NCT02031055CI-TRIAL-00080449completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS-102 tablets | Drug | — | UNRESOLVED |
| TAS-102 with a light tracer dose of [14C]FTD | Drug | — | UNRESOLVED |
| TAS-102 with a light tracer dose of [14C] TPI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAS-102 with light tracer dose of [14C]FTD
- interventionNames
- Drug: TAS-102 with a light tracer dose of [14C]FTD
- Drug: TAS-102 tablets
- type
- EXPERIMENTAL
- label
- TAS-102 with light tracer dose of [14C]TPI
- interventionNames
- Drug: TAS-102 with a light tracer dose of [14C] TPI
- Drug: TAS-102 tablets
Primary outcomes (4)
- measure
- Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI
- timeFrame
- Day 1 through day 8 (through 168 hours postdose)
- description
- Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose. For \[14C\]FTD only, samples of CO2 will be trapped from expired air immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.