ONO-4538 Phase II Rollover Study (ONO-4538-98)
Phase 2
Recruiting
- Conditions
- Pan-tumor
- Interventions
- Registration Number
- NCT04566380
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
- Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit
Exclusion Criteria
- Participant judged to be incapable of providing consent for reasons such as concurrent dementia
- Participant judged by the investigator to be inappropriate as participants of this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-4538 Monotherapy cohort ONO-4538 480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice Combination therapy cohort ONO-4538 ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. Combination therapy cohort S-1 ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. Combination therapy cohort oxaliplatin ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. Combination therapy cohort bevacizumab ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. Combination therapy cohort capecitabine ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. Combination therapy cohort temozolomide ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (Aes) From Day 1 up to 28 days after the end of the treatment phase (non)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Chiba Clinical Site1
🇯🇵Kashiwa, Chiba, Japan
Ehime Clinical Site1
🇯🇵Matsuyama, Ehime, Japan
Fukuoka Clinical Site1
🇯🇵Kurume, Fukuoka, Japan
Hokkaido Clinical Site1
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Clinical Site1
🇯🇵Akashi, Hyogo, Japan
Kanagawa Clinical Site1
🇯🇵Yokohama, Kanagawa, Japan
Oita Clinical Site1
🇯🇵Yufu, Oita, Japan
Osaka Clinical Site1
🇯🇵Suita, Osaka, Japan
Osaka Clinical Site3
🇯🇵Takatsuki, Osaka, Japan
Saitama Clinical Site1
🇯🇵Hidaka, Saitama, Japan
Scroll for more (28 remaining)Chiba Clinical Site1🇯🇵Kashiwa, Chiba, Japan