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This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-114/S-1 | Experimental | TAS-114 plus S-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-114 + S-1 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of TAS-114 when used in combination with S-1 | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 years | |
| Response rate | 4 years |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Kashiwanoha, Kashiwa-shi | Chiba | 277-8577 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30511200 | Derived | Doi 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. |
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| ID | Term |
|---|---|
| C000657359 | TAS-114 |
| C079198 | S 1 (combination) |
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| Disease control rate | 4 years |
| Progression free survival | 4 years |