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Trial record 1 of 1 for:    ONO-4538-12
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Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02267343
Recruitment Status : Active, not recruiting
First Posted : October 17, 2014
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

October 9, 2014
October 17, 2014
October 2, 2018
October 2014
August 2016   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle ]
Same as current
Complete list of historical versions of study NCT02267343 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle ]
  • Objective response rate [ Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle ]
  • Duration of response [ Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle ]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]
  • Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]
Same as current
Not Provided
Not Provided
 
Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: ONO-4538
  • Drug: Placebo
  • Experimental: ONO-4538 Arm
    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
    Intervention: Drug: ONO-4538
  • Placebo Comparator: Placebo Arm
    Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Intervention: Drug: Placebo
Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
Same as current
Not Provided
August 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
 
NCT02267343
ONO-4538-12
Yes
Not Provided
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
September 2018

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