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NCT Number: NCT02746796

Study of ONO-4538 in Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Aichi Clinical Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4538

Drug

Oxaliplatin

Drug

Tegafur- Gimeracil-Oteracil potassium

Drug

Capecitabine

Drug

Placebo

Drug

Primary outcomes

  1. Progression-free survival (central assessment by IRRC) (only Part 2)

    Time frame: Up to study completion (estimated time frame: 48 months)

  2. Overall survival (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

Secondary outcomes

  1. Objective response rate (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  2. Progression-free survival (assessment by the site investigator)(only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  3. Duration of response (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  4. Disease control rate (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  5. Time to response (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  6. Best overall response (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  7. Percent change in the sum of diameters of target lesions (only Part 2)

    Time frame: Up to study completion (estimated time frame: 54 months)

  8. Safety will be analyzed through the incidence of adverse events, serious adverse events

    Time frame: Up to 28 days from last dose

  9. Safety will be analyzed through the incidence of laboratory abnormalities

    Time frame: Up to 28 days from last dose

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Apr 21, 2016
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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