A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
Conditions
Advanced Solid Tumors
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TAS-114 + S-1
Type: Drug
Overall Status
Recruiting
Summary
This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Location
Site 01
Kashiwanoha, Kashiwa-shi, Chiba, Japan
Status: Recruiting
Contact: Toshihiko Doi, M.D. - +81-4-7133-1111 - tdoi@east.ncc.go.jp
Start Date
June 2012
Completion Date
April 2016
Sponsors
Taiho Pharmaceutical Co., Ltd.
Source
Taiho Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page