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

This study is currently recruiting participants.
Verified February 2014 by Taiho Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01610479
First received: May 25, 2012
Last updated: February 18, 2014
Last verified: February 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 [ Designated as safety issue: Yes ]

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) [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Disease control rate [ Designated as safety issue: No ]
  • Progression free survival [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610479

Locations
Japan
Site 01 Recruiting
Kashiwanoha, Kashiwa-shi, Chiba, Japan, 277-8577
Contact: Toshihiko Doi, M.D.    +81-4-7133-1111    tdoi@east.ncc.go.jp   
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
  More Information

No publications provided

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: February 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014