ONO-4538 Phase II Rollover Study (ONO-4538-98)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ONO-4538, oxaliplatin, S-1, capecitabine.
- Who it may be relevant to
- Registry conditions: Pan-tumor. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan, South Korea, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Drug ONO-4538
IV infusion over 30 minutes - Drug oxaliplatin
IV infusion over 2 hours - Drug S-1
Administered orally twice daily - Drug capecitabine
Administered orally twice daily - Drug bevacizumab
IV infusion over 30 minutes - Drug temozolomide
Administered orally once daily for 5 days every 28 days
Primary outcome measures
- Incidence of Adverse Events (Aes) [Time frame: From Day 1 up to 28 days after the end of the treatment phase]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 22 centers
- Chiba Clinical Site1 — Kashiwa
- Ehime Clinical Site1 — Matsuyama
- Fukuoka Clinical Site1 — Kurume
- Hokkaido Clinical Site1 — Sapporo
- Hyogo Clinical Site1 — Akashi
- Kanagawa Clinical Site1 — Yokohama
- Oita Clinical Site1 — Yufu
- Osaka Clinical Site1 — Suita
- … and 14 more centers
South Korea · 9 centers
- Daegu Clinical Site1 — Daegu
- Gyeonggi-do Clinical site1 — Gyeonggi-do
- Incheon Clinical Site1 — Incheon
- Seoul Clinical Site1 — Seoul
- Seoul Clinical Site2 — Seoul
- Seoul Clinical Site3 — Seoul
- Seoul Clinical Site4 — Seoul
- Seoul Clinical Site5 — Seoul
- … and 1 more center
Taiwan · 7 centers
- Kaohsiung Clinical Site1 — Kaohsiung City
- Kaohsiung Clinical Site2 — Kaohsiung City
- Tainan Clinical Site1 — Tainan
- Tainan Clinical Site2 — Tainan
- Taipei Clinical Site1 — Taipei
- Taipei Clinical Site2 — Taipei
- Taoyuan Clinical Site1 — Taoyuan
Identifiers
NCT: NCT04566380 · ONO-4538-98 · jRCT2080225345