Clinical trial NCT03232593: A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
Official title: Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Carcinoma, Non-Small Cell Lung
Small Cell Lung Carcinoma
Triple Negative Breast Carcinoma
Hepatocellular Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 1758
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.

Brief summary: This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.


Eligibility criteria: Inclusion Criteria:

* Participants who are administered with atezolizumab for the locally approved indications

Exclusion Criteria:

* Participants with a known hypersensitivity to atezolizumab or to any of the excipients

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Approximately 6 years
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Approximately 6 years
measure: Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1
timeFrame: Approximately 6 years
measure: Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1
timeFrame: Approximately 6 years
measure: Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1
timeFrame: Approximately 6 years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongnam Inst.of Radiological & Medical Sciences
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Donga Uni Medical Center; Pulmonary
city: Busan
country: Korea, Republic of
facility: Pusan University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan University Hospital; Hemato-oncology
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital; Pulmonology
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Hallym University Medical Center Chuncheon Sacred Heart Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Bucheon St Mary's hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Hwaseong Si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Jeollabuk-do
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jeonlabuk-do
country: Korea, Republic of
facility: Wonkwang University School of Medicine & Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary's Hoapital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangdong Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: ChungAng University Hospital
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System; Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Division of Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital; Urology
city: Seoul
country: Korea, Republic of
facility: Korea Uni Anam Hospital; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Hospital Seoul
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital; hemato-oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: