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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd. Identifier:
First received: May 25, 2012
Last updated: February 6, 2017
Last verified: February 2017
This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Condition Intervention Phase
Advanced Solid Tumors
Drug: TAS-114 + S-1
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Maximum tolerated dose of TAS-114 when used in combination with S-1 [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • 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 ]
  • Response rate [ Time Frame: 4 years ]
  • Disease control rate [ Time Frame: 4 years ]
  • Progression free survival [ Time Frame: 4 years ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS-114/S-1
TAS-114 plus S-1
Drug: TAS-114 + S-1

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.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01610479

Site 01
Kashiwanoha, Kashiwa-shi, Chiba, Japan, 277-8577
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT01610479     History of Changes
Other Study ID Numbers: Taiho10050020
Study First Received: May 25, 2012
Last Updated: February 6, 2017 processed this record on April 27, 2017