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

Last updated: May 2, 2024
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

temozolomide

S-1

capecitabine

Clinical Study ID

NCT04566380
ONO-4538-98
  • Ages > 16
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Participant who is being treated with ONO-4538 as monotherapy or in Combination withOther Therapies in clinical trials
  2. Participant who is eligible for ONO-4538 monotherapy or in combination with othertherapies as per the clinical trials, and/or investigator-assessed clinical benefit

Exclusion

Exclusion Criteria:

  1. Participant judged to be incapable of providing consent for reasons such as concurrentdementia
  2. Participant judged by the investigator to be inappropriate as participants of thisstudy

Study Design

Total Participants: 59
Treatment Group(s): 6
Primary Treatment: temozolomide
Phase: 2
Study Start date:
September 10, 2020
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Chiba Clinical Site1

    Kashiwa, Chiba
    Japan

    Active - Recruiting

  • Ehime Clinical Site1

    Matsuyama, Ehime
    Japan

    Completed

  • Fukuoka Clinical Site1

    Kurume, Fukuoka
    Japan

    Active - Recruiting

  • Hokkaido Clinical Site1

    Sapporo, Hokkaido
    Japan

    Active - Recruiting

  • Hyogo Clinical Site1

    Akashi, Hyogo
    Japan

    Active - Recruiting

  • Kanagawa Clinical Site1

    Yokohama, Kanagawa
    Japan

    Active - Recruiting

  • Oita Clinical Site1

    Yufu, Oita
    Japan

    Active - Recruiting

  • Osaka Clinical Site1

    Suita, Osaka
    Japan

    Active - Recruiting

  • Osaka Clinical Site3

    Takatsuki, Osaka
    Japan

    Active - Recruiting

  • Saitama Clinical Site1

    Hidaka, Saitama
    Japan

    Active - Recruiting

  • Saitama Clinical Site2

    Kitaadachi-gun, Saitama
    Japan

    Active - Recruiting

  • Tokyo Clinical Site3

    Bunkyo-ku, Tokyo
    Japan

    Active - Recruiting

  • Tokyo Clinical Site2

    Chuo-ku, Tokyo
    Japan

    Active - Recruiting

  • Tokyo Clinical Site1

    Koto-ku, Tokyo
    Japan

    Active - Recruiting

  • Tokyo Clinical Site4

    Shinjuku-ku, Tokyo
    Japan

    Active - Recruiting

  • Chiba Clinical Site2

    Chiba,
    Japan

    Active - Recruiting

  • Fukuoka Clinical Site2

    Fukuoka,
    Japan

    Active - Recruiting

  • Fukuoka Clinical Site3

    Fukuoka,
    Japan

    Active - Recruiting

  • Hiroshima Clinical Site1

    Hiroshima,
    Japan

    Active - Recruiting

  • Kyoto Clinical Site1

    Kyoto,
    Japan

    Active - Recruiting

  • Okayama Clinical Site1

    Okayama,
    Japan

    Active - Recruiting

  • Osaka Clinical Site2

    Osaka,
    Japan

    Active - Recruiting

  • Daegu Clinical Site1

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Gyeonggi-do Clinical site1

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Incheon Clinical Site1

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Seoul Clinical Site1

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Clinical Site2

    Seoul,
    Korea, Republic of

    Completed

  • Seoul Clinical Site3

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Clinical Site4

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Clinical Site5

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Clinical Site6

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kaohsiung Clinical Site1

    Kaohsiung,
    Taiwan

    Completed

  • Kaohsiung Clinical Site2

    Kaohsiung,
    Taiwan

    Completed

  • Tainan Clinical Site1

    Tainan,
    Taiwan

    Active - Recruiting

  • Tainan Clinical Site2

    Tainan,
    Taiwan

    Active - Recruiting

  • Taipei Clinical Site1

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Clinical Site2

    Taipei,
    Taiwan

    Active - Recruiting

  • Taoyuan Clinical Site1

    Taoyuan,
    Taiwan

    Active - Recruiting

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