Clinical trial · Interventional
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone
NCT01867866CI-TRIAL-00080470completedPhase 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 compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS-102 | Drug | — | UNRESOLVED |
| Trifluridine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAS-102
- interventionNames
- Drug: TAS-102
- type
- EXPERIMENTAL
- label
- FTD (Trifluridine)
- interventionNames
- Drug: Trifluridine
Primary outcomes (1)
- measure
- FTD pharmacokinetic parameters AUC0-last and Cmax
- timeFrame
- Day 1 of Cycle 1
Secondary outcomes (5)
- measure
- FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.