Study of ONO-4538 in Gastric Cancer

Ono Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: ONO-4538; Drug: Oxaliplatin; Drug: Placebo; Drug: Tegafur- Gimeracil-Oteracil potassium; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02746796

ONO-4538-37

Details and patient eligibility

About

The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.

Enrollment: 680 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
• Have measurable lesions as defined in RECIST Guideline Version 1.1
• ECOG PS score 0 or 1
• Have a life expectancy of at least 3 months

Exclusion criteria

• Have multiple cancers
• Have a current or past history of severe hypersensitivity to any other antibody products
• 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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680 participants in 4 patient groups, including a placebo group

ONO-4538 + SOX Therapy Cohort (Part 1)

Experimental group

Description:

ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (BSA) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Treatment:

Drug: Oxaliplatin

Drug: ONO-4538

Drug: Tegafur- Gimeracil-Oteracil potassium

ONO-4538 + CapeOX Therapy Cohort (Part 1)

Experimental group

Description:

ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1200 - 2100 mg bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Treatment:

Drug: Oxaliplatin

Drug: ONO-4538

Drug: Capecitabine

ONO-4538 + chemotherapy group (Part 2)

Experimental group

Description:

With regard to the ONO-4538 + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Treatment:

Drug: Oxaliplatin

Drug: ONO-4538

Drug: Tegafur- Gimeracil-Oteracil potassium

Drug: Capecitabine

Placebo + Chemotherapy group (Part 2)

Placebo Comparator group

Description:

With regard to the placebo + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. Placebo solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Treatment:

Drug: Placebo

Drug: Oxaliplatin

Drug: Tegafur- Gimeracil-Oteracil potassium

Drug: Capecitabine