## Protocol Section
### Identification Module
**NCT ID:** NCT01610479

**Brief Title:** A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

**Official Title:** A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

#### Organization Study ID Info
**ID:** Taiho10050020
#### Organization
**Class:** INDUSTRY
**Full Name:** Taiho Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2017-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-04

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-02

**Type:** ACTUAL

#### Start Date
**Date:** 2012-06

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2012-06-04
**Type:** ESTIMATED
**Study First Submit Date:** 2012-05-25
**Study First Submit QC Date:** 2012-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Taiho Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Advanced Solid Tumors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** TAS-114 plus S-1

**Intervention Names:**

- Drug: TAS-114 + S-1

**Label:** TAS-114/S-1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TAS-114/S-1

**Name:** TAS-114 + S-1

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Maximum tolerated dose of TAS-114 when used in combination with S-1

**Time Frame:** 4 years

#### Secondary Outcomes

**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)

**Time Frame:** 4 years

**Measure:** Response rate

**Time Frame:** 4 years

**Measure:** Disease control rate

**Time Frame:** 4 years

**Measure:** Progression free survival

**Time Frame:** 4 years

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kashiwanoha, Kashiwa-shi

**Country:** Japan

**Facility:** Site 01

**State:** Chiba

**Zip:** 277-8577

### References Module

#### References

**Citation:** 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.

**PMID:** 30511200

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
