A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

NCT ID: NCT01610479

Last Updated: 2017-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-02-28

Brief Summary

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

Detailed Description

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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

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAS-114/S-1

TAS-114 plus S-1

Group Type EXPERIMENTAL

TAS-114 + S-1

Intervention Type DRUG

Interventions

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TAS-114 + S-1

Intervention Type DRUG

Eligibility Criteria

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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 Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 01

Kashiwanoha, Kashiwa-shi, Chiba, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 30511200 (View on PubMed)

Other Identifiers

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Taiho10050020

Identifier Type: -

Identifier Source: org_study_id

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