RecruitingPhase 2NCT04566380

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

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)


Sponsor

Ono Pharmaceutical Co. Ltd

Enrollment

59 participants

Start Date

Sep 10, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGONO-4538

IV infusion over 30 minutes

DRUGoxaliplatin

IV infusion over 2 hours

DRUGS-1

Administered orally twice daily

DRUGcapecitabine

Administered orally twice daily

DRUGbevacizumab

IV infusion over 30 minutes

DRUGtemozolomide

Administered orally once daily for 5 days every 28 days


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, Hyōgo, Japan

Kanagawa Clinical Site1

Yokohama, Kanagawa, Japan

Oita Clinical Site1

Yufu, Oita Prefecture, Japan

Osaka Clinical Site1

Suita, Osaka, Japan

Osaka Clinical Site3

Takatsuki, Osaka, Japan

Saitama Clinical Site1

Hidaka, Saitama, Japan

Saitama Clinical Site2

Kitaadachi-gun, Saitama, Japan

Tokyo Clinical Site3

Bunkyo-ku, Tokyo, Japan

Tokyo Clinical Site2

Chuo-ku, Tokyo, Japan

Tokyo Clinical Site1

Koto-ku, Tokyo, Japan

Tokyo Clinical Site4

Shinjuku-ku, Tokyo, Japan

Chiba Clinical Site2

Chiba, Japan

Fukuoka Clinical Site2

Fukuoka, Japan

Fukuoka Clinical Site3

Fukuoka, Japan

Hiroshima Clinical Site1

Hiroshima, Japan

Kyoto Clinical Site1

Kyoto, Japan

Okayama Clinical Site1

Okayama, Japan

Osaka Clinical Site2

Osaka, Japan

Daegu Clinical Site1

Daegu, South Korea

Gyeonggi-do Clinical site1

Gyeonggi-do, South Korea

Incheon Clinical Site1

Incheon, South Korea

Seoul Clinical Site1

Seoul, South Korea

Seoul Clinical Site2

Seoul, South Korea

Seoul Clinical Site3

Seoul, South Korea

Seoul Clinical Site4

Seoul, South Korea

Seoul Clinical Site5

Seoul, South Korea

Seoul Clinical Site6

Seoul, South Korea

Kaohsiung Clinical Site1

Kaohsiung City, Taiwan

Kaohsiung Clinical Site2

Kaohsiung City, Taiwan

Tainan Clinical Site1

Tainan, Taiwan

Tainan Clinical Site2

Tainan, Taiwan

Taipei Clinical Site1

Taipei, Taiwan

Taipei Clinical Site2

Taipei, Taiwan

Taoyuan Clinical Site1

Taoyuan District, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04566380