Clinical trial · Interventional
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAS-102 in Patients With Advanced Solid Tumors and Varying Degrees of Renal Impairment
NCT02301117CI-TRIAL-00080446completedPhase 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)
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Mild Renal Impairment
- description
- 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
- interventionNames
- Drug: TAS-102
- type
- EXPERIMENTAL
- label
- Moderate Renal Impairment
- description
- 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
- interventionNames
- Drug: TAS-102
- type
- EXPERIMENTAL
- label
- Severe Renal Impairment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 1. Has provided written informed consent 2. Has advanced solid tumors (excluding breast cancer) 3. Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis 4. ECOG performance status of ≤2 5. Is able to take medications orally 6. Has adequate organ function 7. 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 1. Certain serious illnesses or medical condition(s) 2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration 3. Has received TAS-102 4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 5. Is a pregnant or lactating female
References
Publications (1)
- DERIVEDSaif MW, Becerra CR, Fakih MG, Sun W, Popovic L, Krishnamurthi S, George TJ, Rudek MA, Shepard DR, Skopek J, Sramek V, Zaric B, Yamamiya I, Benhadji KA, Hamada K, He Y, Rosen L. A phase I, open-label study evaluating the safety and pharmacokinetics of trifluridine/tipiracil in patients with advanced solid tumors and varying degrees of renal impairment. Cancer Chemother Pharmacol. 2021 Sep;88(3):485-497. doi: 10.1007/s00280-021-04308-z. Epub 2021 Jun 7. PMID 34097100