Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Placebo; Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267343

ONO-4538-12

Details and patient eligibility

About

The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.

Enrollment: 493 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men & women ≥20 years of age
• Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)
• Histologically confirmed adenocarcinoma
• Refractory to or intolerant of standard therapy
• ECOG Performance Status score 0 or 1
• A life expectancy of at least 3 months

Exclusion criteria

• Current or past history of severe hypersensitivity to any other antibody products
• Patients with multiple primary cancers
• Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
• Patients with active, known or suspected autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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493 participants in 2 patient groups, including a placebo group

ONO-4538 Arm

Experimental group

Description:

ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Drug: ONO-4538

Placebo Arm

Placebo Comparator group

Description:

Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Drug: Placebo