Trials / Completed
CompletedNCT02746796
Study of ONO-4538 in Gastric Cancer
ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 680 (estimated)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4538 | |
| DRUG | Oxaliplatin | |
| DRUG | Tegafur- Gimeracil-Oteracil potassium | |
| DRUG | Capecitabine | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2020-01-01
- Completion
- 2022-11-17
- First posted
- 2016-04-21
- Last updated
- 2024-05-03
Locations
130 sites across 3 countries: Japan, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT02746796. Inclusion in this directory is not an endorsement.