Long-term safety evaluation of ONO-4538 in cancer patients
A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)
This study is testing the long-term safety of the cancer treatment ONO-4538 in patients with different tumors who are already receiving this medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 38 sites (Kashiwa, Chiba and 37 other locations) |
| Trial ID | NCT04566380 on ClinicalTrials.gov |
What this trial studies
This study aims to confirm the long-term safety of ONO-4538 in participants with various tumors who are receiving ONO-4538 either alone or in combination with other therapies. Participants must be currently treated with ONO-4538 as part of ongoing clinical trials. The study will monitor the safety profile and any adverse effects associated with the treatment over an extended period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients currently receiving ONO-4538 as part of a clinical trial for their cancer treatment.
Not a fit: Patients who are unable to provide consent due to cognitive impairments or those deemed inappropriate by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of ONO-4538, potentially leading to improved treatment options for cancer patients.
How similar studies have performed: Other studies evaluating the safety of similar therapies have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials 2. 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: 1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia 2. Participant judged by the investigator to be inappropriate as participants of this study
Where this trial is running
Kashiwa, Chiba and 37 other locations
- Chiba Clinical Site1 — Kashiwa, Chiba, Japan (Recruiting)
- Ehime Clinical Site1 — Matsuyama, Ehime, Japan (Completed)
- Fukuoka Clinical Site1 — Kurume, Fukuoka, Japan (Recruiting)
- Hokkaido Clinical Site1 — Sapporo, Hokkaido, Japan (Recruiting)
- Hyogo Clinical Site1 — Akashi, Hyōgo, Japan (Recruiting)
- Kanagawa Clinical Site1 — Yokohama, Kanagawa, Japan (Recruiting)
- Oita Clinical Site1 — Yufu, Oita Prefecture, Japan (Recruiting)
- Osaka Clinical Site1 — Suita, Osaka, Japan (Recruiting)
- Osaka Clinical Site3 — Takatsuki, Osaka, Japan (Recruiting)
- Saitama Clinical Site1 — Hidaka, Saitama, Japan (Recruiting)
- Saitama Clinical Site2 — Kitaadachi-gun, Saitama, Japan (Recruiting)
- Tokyo Clinical Site3 — Bunkyo-ku, Tokyo, Japan (Recruiting)
- Tokyo Clinical Site2 — Chuo-ku, Tokyo, Japan (Recruiting)
- Tokyo Clinical Site1 — Koto-ku, Tokyo, Japan (Recruiting)
- Tokyo Clinical Site4 — Shinjuku-ku, Tokyo, Japan (Recruiting)
- Chiba Clinical Site2 — Chiba, Japan (Recruiting)
- Fukuoka Clinical Site2 — Fukuoka, Japan (Recruiting)
- Fukuoka Clinical Site3 — Fukuoka, Japan (Recruiting)
- Hiroshima Clinical Site1 — Hiroshima, Japan (Recruiting)
- Kyoto Clinical Site1 — Kyoto, Japan (Recruiting)
- Okayama Clinical Site1 — Okayama, Japan (Recruiting)
- Osaka Clinical Site2 — Osaka, Japan (Recruiting)
- Daegu Clinical Site1 — Daegu, South Korea (Recruiting)
- Gyeonggi-do Clinical site1 — Gyeonggi-do, South Korea (Recruiting)
- Incheon Clinical Site1 — Incheon, South Korea (Recruiting)
- Seoul Clinical Site1 — Seoul, South Korea (Recruiting)
- Seoul Clinical Site2 — Seoul, South Korea (Completed)
- Seoul Clinical Site3 — Seoul, South Korea (Recruiting)
- Seoul Clinical Site4 — Seoul, South Korea (Recruiting)
- Seoul Clinical Site5 — Seoul, South Korea (Recruiting)
- Seoul Clinical Site6 — Seoul, South Korea (Recruiting)
- Kaohsiung Clinical Site1 — Kaohsiung City, Taiwan (Completed)
- Kaohsiung Clinical Site2 — Kaohsiung City, Taiwan (Completed)
- Tainan Clinical Site1 — Tainan, Taiwan (Recruiting)
- Tainan Clinical Site2 — Tainan, Taiwan (Recruiting)
- Taipei Clinical Site1 — Taipei, Taiwan (Recruiting)
- Taipei Clinical Site2 — Taipei, Taiwan (Recruiting)
- Taoyuan Clinical Site1 — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.