ONO-4538 Phase II Rollover Study (ONO-4538-98)

NCT04566380 · tracked via the Priya Life Science Japan tracker

Sponsor

Ono Pharmaceutical Co., Ltd

Phase

Phase 2

Started

2020-09-10

Last updated

2025-06-03

Condition(s) studied

Pan-tumor

Investigational drug(s) / intervention(s)

ONO-4538 →oxaliplatin →S-1 →capecitabine →bevacizumab →temozolomide →

ONO-4538: IV infusion over 30 minutes

oxaliplatin: IV infusion over 2 hours

S-1: Administered orally twice daily

capecitabine: Administered orally twice daily

bevacizumab: IV infusion over 30 minutes

temozolomide: Administered orally once daily for 5 days every 28 days

Study 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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of Adverse Events (Aes) — From Day 1 up to 28 days after the end of the treatment phase
(non)

Trial sites (38)

Facility	City	Region	Status
Chiba Clinical Site1	Kashiwa	Chiba	Recruiting
Ehime Clinical Site1	Matsuyama	Ehime	Completed
Fukuoka Clinical Site1	Kurume	Fukuoka	Recruiting
Hokkaido Clinical Site1	Sapporo	Hokkaido	Recruiting
Hyogo Clinical Site1	Akashi	Hyōgo	Recruiting
Kanagawa Clinical Site1	Yokohama	Kanagawa	Recruiting
Oita Clinical Site1	Yufu	Oita Prefecture	Recruiting
Osaka Clinical Site1	Suita	Osaka	Recruiting
Osaka Clinical Site3	Takatsuki	Osaka	Recruiting
Saitama Clinical Site1	Hidaka	Saitama	Recruiting
Saitama Clinical Site2	Kitaadachi-gun	Saitama	Recruiting
Tokyo Clinical Site3	Bunkyo-ku	Tokyo	Recruiting
Tokyo Clinical Site2	Chuo-ku	Tokyo	Recruiting
Tokyo Clinical Site1	Koto-ku	Tokyo	Recruiting
Tokyo Clinical Site4	Shinjuku-ku	Tokyo	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

On this site

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More Ono Pharmaceutical Co., Ltd. trials in Japan

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An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer Active, not recruiting

A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors Active, not recruiting

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL Recruiting

A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04566380 on ClinicalTrials.gov ↗ ← All trials in Japan