Clinical trial · Interventional
A Phase I Study of TAS-102 in Solid Tumors
A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
NCT02261532CI-TRIAL-00082539completedPhase 1Results postedClinicalTrials.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 primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.
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 or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS-102
- interventionNames
- Drug: TAS-102
Primary outcomes (3)
- measure
- Cmax (Maximum Plasma Concentration) of FTD
- timeFrame
- Multiple time points on Day 1 and Day 12 of Cycle 1.
- measure
- Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
- timeFrame
- Multiple time points on Day 1 and Day 12 of Cycle 1.
- measure
- AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
- timeFrame
- Multiple time points on Day 1 and Day 12 of Cycle 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Has provided written informed consent prior to performance of any study procedure. * 2\. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor. * 3\. Is able to take medications orally. * 4\. Has adequate organ function (bone marrow, kidney and liver). * 5\. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * 1\. Has received TAS-102. * 2\. Has suffered serious complications. * 3\. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies. * 4\. Has had prior gastrectomy. * 5\. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
References
Publications (1)
- DERIVEDWang X, Zhou J, Li Y, Ge Y, Zhou Y, Bai C, Shen L. Pharmacokinetics, Safety, and Preliminary Efficacy of Oral Trifluridine/Tipiracil in Chinese Patients with Solid Tumors: A Phase 1b, Open-Label Study. Clin Pharmacol. 2020 Apr 9;12:21-33. doi: 10.2147/CPAA.S232104. eCollection 2020. PMID 32308505