A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
Phase 1
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
Trial Information
A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of TAS-114 when used in combination with S-1
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
Taiho10050020
NCT ID:
NCT01610479
Start Date:
June 2012
Completion Date:
April 2014
Related Keywords:
- Advanced Solid Tumors
- Neoplasms
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