Clinical trial NCT04566380: ONO-4538 Phase II Rollover Study (ONO-4538-98)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pan-tumor
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 outcomes:
measure: Incidence of Adverse Events (Aes)
timeFrame: From Day 1 up to 28 days after the end of the treatment phase
Secondary outcomes:
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Chiba Clinical Site1
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Clinical Site1
state: Ehime
city: Kurume
country: Japan
facility: Fukuoka Clinical Site1
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site1
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Clinical Site1
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site1
state: Kanagawa
city: Yufu
country: Japan
facility: Oita Clinical Site1
state: Oita
city: Suita
country: Japan
facility: Osaka Clinical Site1
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Clinical Site3
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Clinical Site1
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Clinical Site2
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site3
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Koto-ku
country: Japan
facility: Tokyo Clinical Site1
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site4
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Clinical Site2
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site2
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site3
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site1
city: Kyoto
country: Japan
facility: Kyoto Clinical Site1
city: Okayama
country: Japan
facility: Okayama Clinical Site1
city: Osaka
country: Japan
facility: Osaka Clinical Site2
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site1
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical site1
city: Incheon
country: Korea, Republic of
facility: Incheon Clinical Site1
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site1
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site2
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site3
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site4
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site5
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site6
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site1
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site2
city: Tainan
country: Taiwan
facility: Tainan Clinical Site1
city: Tainan
country: Taiwan
facility: Tainan Clinical Site2
city: Taipei
country: Taiwan
facility: Taipei Clinical Site1
city: Taipei
country: Taiwan
facility: Taipei Clinical Site2
city: Taoyuan
country: Taiwan
facility: Taoyuan Clinical Site1
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: