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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 : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 21, 2016
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Progression-free survival (central assessment by IRRC) (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 48 months) ]
  • Overall survival (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Objective response rate (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 12 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Objective response rate (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Progression-free survival (assessment by the site investigator)(only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Duration of response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Disease control rate (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Time to response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Best overall response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Percent change in the sum of diameters of target lesions (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Up to 28 days from last dose ]
  • Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Up to 28 days from last dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
  • Overall survival (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Progression-free survival (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Duration of response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Disease control rate (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Time to response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Best overall response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Percent change in the sum of diameters of target lesions (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 24 months) ]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Up to 28 days from last dose ]
  • Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Up to 28 days from last dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ONO-4538 in Gastric Cancer
Official Title  ICMJE ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: ONO-4538
  • Drug: Oxaliplatin
  • Drug: Tegafur- Gimeracil-Oteracil potassium
  • Drug: Capecitabine
  • Drug: Placebo
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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.

    Interventions:
    • 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.

    Interventions:
    • 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.

    Interventions:
    • Drug: Oxaliplatin
    • Drug: Tegafur- Gimeracil-Oteracil potassium
    • Drug: Capecitabine
    • Drug: Placebo
Publications * Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
680
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2016)
268
Estimated Study Completion Date  ICMJE March 2022
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02746796
Other Study ID Numbers  ICMJE ONO-4538-37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
URL: https://www.ono.co.jp/eng/rd/policy.html
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP