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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01610479
First received: May 25, 2012
Last updated: August 2, 2017
Last verified: August 2017
  Purpose
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: None (Open Label)
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
Study Completion Date: February 2017
Primary Completion Date: February 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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610479

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

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01610479     History of Changes
Other Study ID Numbers: Taiho10050020
Study First Received: May 25, 2012
Last Updated: August 2, 2017

ClinicalTrials.gov processed this record on September 19, 2017