Clinical trial · Interventional
A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
NCT01610479CI-TRIAL-00028949completedPhase 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)
This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
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-114 + S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS-114/S-1
- description
- TAS-114 plus S-1
- interventionNames
- Drug: TAS-114 + S-1
Primary outcomes (1)
- measure
- Maximum tolerated dose of TAS-114 when used in combination with S-1
- timeFrame
- 4 years
Secondary outcomes (4)
- measure
- Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite)
- timeFrame
- 4 years
- measure
- Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy of at least 3 months * Histological or cytological documentation of advanced solid tumors * ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group) * Adequate bone marrow, liver and renal function * Women of childbearing potential and men must agree to use adequate contraception
References
Publications (1)
- DERIVEDDoi T, Yoh K, Shitara K, Takahashi H, Ueno M, Kobayashi S, Morimoto M, Okusaka T, Ueno H, Morizane C, Okano N, Nagashima F, Furuse J. First-in-human phase 1 study of novel dUTPase inhibitor TAS-114 in combination with S-1 in Japanese patients with advanced solid tumors. Invest New Drugs. 2019 Jun;37(3):507-518. doi: 10.1007/s10637-018-0697-3. Epub 2018 Dec 4. PMID 30511200