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

This study is currently recruiting participants. (see Contacts and Locations)
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
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 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 July 24, 2014