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Study of ONO-4538 in Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02746796
Recruitment Status : Active, not recruiting
First Posted : April 21, 2016
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: ONO-4538 Drug: Oxaliplatin Drug: Tegafur- Gimeracil-Oteracil potassium Drug: Capecitabine Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
Actual Study Start Date : March 2016
Actual Primary Completion Date : January 2020
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ONO-4538 + SOX Therapy Cohort (Part 1)

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.

 Drug: ONO-4538
Drug: Oxaliplatin
Drug: Tegafur- Gimeracil-Oteracil potassium
Experimental: ONO-4538 + CapeOX Therapy Cohort (Part 1)

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.

 Drug: ONO-4538
Drug: Oxaliplatin
Drug: Capecitabine
Experimental: ONO-4538 + chemotherapy group (Part 2)

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.

 Drug: ONO-4538
Drug: Oxaliplatin
Drug: Tegafur- Gimeracil-Oteracil potassium
Drug: Capecitabine
Placebo Comparator: Placebo + Chemotherapy group (Part 2)

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.

 Drug: Oxaliplatin
Drug: Tegafur- Gimeracil-Oteracil potassium
Drug: Capecitabine
Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746796


Locations
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Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT02746796    
Other Study ID Numbers: ONO-4538-37
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono.co.jp/eng/rd/policy.html
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
 Tegafur
Oxaliplatin
Nivolumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors