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

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ClinicalTrials.gov Identifier: NCT01610479
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TAS-114 + S-1 Phase 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: TAS-114/S-1
TAS-114 plus S-1
Drug: TAS-114 + S-1



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

Secondary Outcome Measures :
  1. 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 ]
  2. Response rate [ Time Frame: 4 years ]
  3. Disease control rate [ Time Frame: 4 years ]
  4. Progression free survival [ Time Frame: 4 years ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610479


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

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01610479     History of Changes
Other Study ID Numbers: Taiho10050020
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017