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

Taiho Pharma

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: TAS-114 + S-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01610479

Taiho10050020

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

TAS-114/S-1

Experimental group

Description:

TAS-114 plus S-1

Treatment:

Drug: TAS-114 + S-1