Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer (SOLAR)

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: TAS-118 plus Oxaliplatin; Drug: S-1 plus Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02322593

10056040

Details and patient eligibility

About

The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.

Enrollment: 711 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patients who are diagnosed as gastric cancer.
• No prior treatment for gastric cancer.
• Negative or unknown for HER2 testing.
• ECOG performance status of 0 or 1.

Key Exclusion Criteria:

• Unmanageable diarrhea.
• Current peripheral sensory neuropathy or paresthesia.
• Pregnant or lactating female.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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711 participants in 2 patient groups

TAS-118/Oxaliplatin

Experimental group

Description:

TAS-118 plus Oxaliplatin

Treatment:

Drug: TAS-118 plus Oxaliplatin

S-1/Cisplatin

Active Comparator group

Description:

S-1 plus Cisplatin

Treatment:

Drug: S-1 plus Cisplatin