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A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03232593
Collaborator
(none)
1,758
Enrollment
56
Locations
56.4
Actual Duration (Months)
31.4
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1758 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
Actual Study Start Date :
Nov 29, 2017
Actual Primary Completion Date :
Aug 12, 2022
Actual Study Completion Date :
Aug 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Participants who Receive Atezolizumab

Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years.

Drug: Atezolizumab
Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.
Other Names:
  • Tecentriq

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [Approximately 6 years]

    Secondary Outcome Measures

    1. Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Approximately 6 years]

    2. Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1 [Approximately 6 years]

    3. Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1 [Approximately 6 years]

    4. Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1 [Approximately 6 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dongnam Inst.of Radiological & Medical Sciences Busan Korea, Republic of 46033
    2 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
    3 Inje university Haeundae Paik Hospital Busan Korea, Republic of 48108
    4 Dong-A University Hospital Busan Korea, Republic of 49201
    5 Pusan National University Hospital Busan Korea, Republic of 49241
    6 Kosin University Gospel Hospital Busan Korea, Republic of 49267
    7 Donga Uni Medical Center; Pulmonary Busan Korea, Republic of 602-715
    8 Pusan University Hospital Busan Korea, Republic of 602-739
    9 Pusan University Hospital; Hemato-oncology Busan Korea, Republic of
    10 Kyungpook National University Medical Center Daegu Korea, Republic of 41404
    11 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
    12 Daegu Catholic University Medical Center Daegu Korea, Republic of 42472
    13 Keimyung University Dongsan Hospital; Pulmonology Daegu Korea, Republic of 42601
    14 Konyang University Hospital Daejeon Korea, Republic of 35365
    15 Hallym University Medical Center Chuncheon Sacred Heart Hospital Gangwon-do Korea, Republic of 24253
    16 Yonsei University Wonju Severance Christian Hospital Gangwon-do Korea, Republic of 26426
    17 Gangneung Asan Hospital Gangwon-do Korea, Republic of
    18 Uijeongbu St. Mary's Hospital Gyeonggi-do Korea, Republic of 11765
    19 CHA Bundang Medical Center Gyeonggi-do Korea, Republic of 13496
    20 Hallym University Sacred Heart Hospital Gyeonggi-do Korea, Republic of 14068
    21 Soonchunhyang University Bucheon Hospital Gyeonggi-do Korea, Republic of 14584
    22 Bucheon St Mary's hospital Gyeonggi-do Korea, Republic of 14647
    23 Korea University Ansan Hospital Gyeonggi-do Korea, Republic of 15355
    24 St. Vincent's Hospital Gyeonggi-do Korea, Republic of 16247
    25 Pusan National University Yangsan Hospital Gyeongsangnam-do Korea, Republic of 50612
    26 Hallym University Dongtan Sacred Heart Hospital Hwaseong Si Korea, Republic of
    27 Chonbuk National University Hospital Jeollabuk-do Korea, Republic of 54907
    28 Chonnam National University Hwasun Hospital Jeollanam-do Korea, Republic of 58128
    29 Wonkwang University School of Medicine & Hospital Jeonlabuk-do Korea, Republic of 54538
    30 Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences Seoul Korea, Republic of 01812
    31 Korea University Anam Hospital Seoul Korea, Republic of 02841
    32 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    33 Eunpyeong St. Mary's Hoapital Seoul Korea, Republic of 03312
    34 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    35 Severance Hospital, Yonsei University Seoul Korea, Republic of 03722
    36 Soonchunhyang University Hospital Seoul Korea, Republic of 04401
    37 Hanyang University Medical Center Seoul Korea, Republic of 04763
    38 Gangdong Kyung Hee University Hospital Seoul Korea, Republic of 05278
    39 VHS Medical Center Seoul Korea, Republic of 05368
    40 Asan Medical Center Seoul Korea, Republic of 05505
    41 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    42 Samsung Medical Center Seoul Korea, Republic of 06351
    43 Seoul St Mary's Hospital Seoul Korea, Republic of 06591
    44 ChungAng University Hospital Seoul Korea, Republic of 06973
    45 Borame Medical Center Seoul Korea, Republic of 07061
    46 Yeouido St. Mary's Hospital Seoul Korea, Republic of 07345
    47 Korea University Guro Hospital Seoul Korea, Republic of 08308
    48 Severance Hospital, Yonsei University Health System; Oncology Seoul Korea, Republic of 120-752
    49 Samsung Medical Centre; Division of Hematology/Oncology Seoul Korea, Republic of 135-710
    50 Ewha Womans University Mokdong Hospital; Urology Seoul Korea, Republic of
    51 Korea Uni Anam Hospital; Internal Medicine Seoul Korea, Republic of
    52 SoonChunHyang University Hospital Seoul Seoul Korea, Republic of
    53 Ulsan University Hosiptal Ulsan Korea, Republic of 44033
    54 Ulsan University Hospital Ulsan Korea, Republic of 44033
    55 Yonsei University Wonju Severance Christian Hospital Wonju-Si Korea, Republic of 220-701
    56 Pusan National University Yangsan Hospital; hemato-oncology Yangsan Korea, Republic of

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03232593
    Other Study ID Numbers:
    • ML39313
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Small Cell Lung Carcinoma
    Atezolizumab

    Study Results

    No Results Posted as of Aug 24, 2022