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NCT01610479 Clinical Trial

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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01610479
Other study ID # Taiho10050020
Secondary ID
Status Completed
Phase Phase 1
First received May 25, 2012
Last updated August 2, 2017
Start date June 2012
Est. completion date February 2017

Study information
Verified date August 2017
Source Taiho Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TAS-114 + S-1

Locations
Country Name City State
Japan Site 01 Kashiwanoha, Kashiwa-shi Chiba

Sponsors (1)
Lead Sponsor Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose of TAS-114 when used in combination with S-1 4 years
Secondary 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
Secondary Response rate 4 years
Secondary Disease control rate 4 years
Secondary Progression free survival 4 years
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