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Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Primary Purpose

Liposarcoma, Dedifferentiated

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 907828
Doxorubicin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liposarcoma, Dedifferentiated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
  • Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF). Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information.
  • Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial.
  • Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available.
  • Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review.
  • Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis.
  • Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt.
  • Adequate organ function

Exclusion Criteria:

  • Known mutation in the TP53 gene (screening for TP53 status is not required).
  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
  • Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative).
  • Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment.
  • Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy).
  • Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
  • Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant).
  • Further exclusion criteria apply

Sites / Locations

  • University of Alabama at Birmingham
  • University of Arizona
  • Precision NextGen Oncology
  • City of Hope
  • University of Southern California
  • University of California San Diego
  • Sarcoma Oncology Center
  • Northern California Kaiser Permanente
  • University of Colorado Denver
  • MedStar Washington Hospital Center
  • Mayo Clinic Cancer Center
  • University of Miami
  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory University
  • Northwestern University
  • Johns Hopkins Hospital
  • Harvard Medical School - Massachusetts General Hospital - Cancer Center
  • Dana-Farber Cancer Institute
  • University of Michigan
  • Mayo Clinic, Rochester
  • Barnes-Jewish Hospital
  • Nebraska Cancer Specialists
  • Roswell Park Cancer Institute
  • University Hospitals of Cleveland
  • The Ohio State University Wexner Medical Center
  • University of Oklahoma
  • Oregon Health and Sciences University
  • Abramson Cancer Center at Pennsylvania Hospital
  • Fox Chase Cancer Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • The University of Texas Southwestern Medical Center
  • The University of Texas MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • Fred Hutchinson Cancer Research Center
  • Froedtert and The Medical College of Wisconsin
  • Chris Obrien Lifehouse
  • Prince of Wales Hospital
  • Princess Alexandra Hospital Division of Cancer Service
  • Ashford Cancer Centre Research
  • Peter MacCallum Cancer Centre
  • Brussels - HOSP Jules Bordet
  • UZ Leuven
  • Cross Cancer Institute (University of Alberta)
  • BC Cancer Agency Vancouver Cancer Centre
  • The Ottawa Hospital
  • Princess Margaret Cancer Centre
  • Maisonneuve-Rosemont Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Cancer Hospital of Chinese Academy of Medical Science
  • Beijing Cancer Hospital
  • Sun Yat-Sen University Cancer Center
  • The First Afiliated Hospital, Sun Yet-sen University
  • Harbin Medical University cancer hospital
  • Hunan Province Tumor Hospital
  • Xiangya Hospital, Central South University
  • The First Hospital of Jilin University
  • Liaoning Cancer Hospital
  • Beijing Jishuitan Hospital
  • Zhongshan Hospital Fudan University
  • West China Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang Cancer Hospital
  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
  • Masaryk Memorial Cancer Institute
  • University Hospital Olomouc
  • University Hospital Motol
  • Aarhus University Hospital
  • Herlev and Gentofte Hospital
  • Comprehensive Cancer Center
  • FONK, Early Phase Oncology Research Unit
  • Institut Bergonie
  • Centre Oscar Lambret
  • Centre Leon Berard
  • HOP Timone
  • Hôpital Cochin
  • CTR Eugène Marquis
  • Institut Universitaire du Cancer Toulouse
  • Gustave Roussy,Cancer Campus
  • Helios Klinikum Bad Saarow
  • Helios Klinikum Berlin-Buch
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Universitätsklinikum Essen AöR
  • Universitätsklinikum Frankfurt
  • Asklepios Kliniken GmbH & Co. KGaA
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Mannheim GmbH
  • Klinikum der Universität München - Campus Großhadern
  • Robert-Bosch-Krankenhaus GmbH
  • Hippokration General Hospital of Athen
  • "Attikon" University General Hospital of Attica
  • Bioclinic Thessaloniki Oncology Clinic
  • Prince of Wales Hospital
  • St. Vincent's University Hospital
  • Istituto Nazionale IRCCS Tumori Fondazione Pascale
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Europeo di Oncologia
  • Istituo Di Candiolo
  • AO Univ. Policlinico P.Giaccone
  • Istituto Oncologico Veneto IRCSS
  • Humanitas Gavazzeni
  • AOU San Luigi Gonzaga
  • Nuovo Ospedale di Prato
  • Policlinico Universitario Campus Bio-Medico Oncologia Medica
  • Aichi Cancer Center Hospital
  • Nagoya University Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Kyushu Cancer Center
  • Kyushu University Hospital
  • Tohoku University Hospital
  • Okayama University Hospital
  • Osaka International Cancer Institute
  • Hokkaido Cancer Center
  • National Cancer Center Hospital
  • Japanese Foundation for Cancer Research
  • Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Antoni van Leeuwenhoek Ziekenhuis
  • Leids Universitair Medisch Centrum Klinische Oncologie
  • Oslo Universitetssykehus HF, Radiumhospitalet
  • Universitetssykehuset Nord-Norge, Tromsø
  • St. Luke Medical Centre
  • IPO Lisboa Francisco Gentil, EPE
  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
  • Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
  • IPO Porto Francisco Gentil, EPE
  • Multidisciplinary Medical Center " Medicina24/7"
  • State Autonomus Healthcare Institution of Moscow "Moscow City Oncology Hospital #62 of Healthcare department of Moscow"
  • JSC "Group of Companies "Medsi"
  • BHI of Omsk region - Clinical Oncology Dispensary
  • Private Medical Institution "Euromedservice"
  • St. Petersburg S.B.H.I.City Oncology Dispensary
  • Hospital Germans Trias i Pujol
  • Hospital Duran i Reynals
  • Hospital Clínico Universitario de Santiago
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Vall d'Hebron
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario La Paz
  • Hospital Universitario HM Sanchinarro
  • Hospital Universitario Virgen de la Victoria
  • Hospital Clínico de Valencia
  • Hospital Universitario Miguel Servet
  • Sahlgrenska Universitetsjukhuset
  • Skånes Universitetssjukhus
  • Karolinska Universitetssjukhuset Stockholm
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital(Linkou)
  • Baskent University Hospital
  • Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Hacettepe Universitesi Tip Fakultesi
  • Trakya Universitesi Tip Fakultesi İç Hastalıklar Onkoloji
  • Medipol University Medical Faculty
  • Addenbrooke's Hospital
  • Velindre Cancer Centre
  • Churchill Hospital
  • University College Hospital
  • The Royal Marsden Hospital
  • Weston Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

BI 907828 low dose

BI 907828 high dose

BI 907828 arm

Doxorubicin arm

Arm Description

Phase II

Phase II

Phase III

Phase II/III

Outcomes

Primary Outcome Measures

Progression-free survival
defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first.

Secondary Outcome Measures

Objective response (OR)
defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.
Duration of objective response (DOR)
defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed objective response (based on blinded central independent review), whichever occurs first.
Overall survival (OS)
defined as the time interval from randomization until death from any cause
Disease control (DC)
defined as a best overall response of CR, PR, or stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (based on blinded central independent review).
Change from baseline in QLQ-C30 (Quality of Life questionnaire C30)
The QLQ C30 rates the overall quality of life in cancer participants. 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function, symptoms and financial difficulties and 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Includes scores for physical functioning, fatigue, pain, global health status.
Change from baseline in EQ-5D5L (European Quality of Life 5 dimensions 5 level)
The EQ-5D-5L is a standardized instrument to assess of health outcome through 5 Likert scale items. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100.
Change from baseline in fatigue
Fatigue symptoms are assessed through 25 items selected from the European Organization for Research and Treatment of Cancer (EORTC) item library. Items use a 4-point scale (1=not at all to 4=very much) similar to the C30.
Change from baseline in pain
Pain symptoms are assessed through 18 items selected from the EORTC item library. Items use a 4-point scale (1=not at all to 4=very much) similar to the C30.
Occurrence of treatment-emergent adverse events (AEs)
Occurrence of treatment-emergent AEs leading to study drug discontinuation

Full Information

First Posted
January 18, 2022
Last Updated
September 26, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05218499
Brief Title
Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
Official Title
Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
May 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liposarcoma, Dedifferentiated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BI 907828 low dose
Arm Type
Experimental
Arm Description
Phase II
Arm Title
BI 907828 high dose
Arm Type
Experimental
Arm Description
Phase II
Arm Title
BI 907828 arm
Arm Type
Experimental
Arm Description
Phase III
Arm Title
Doxorubicin arm
Arm Type
Active Comparator
Arm Description
Phase II/III
Intervention Type
Drug
Intervention Name(s)
BI 907828
Other Intervention Name(s)
Brigimadlin
Intervention Description
BI 907828
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
doxorubicin
Primary Outcome Measure Information:
Title
Progression-free survival
Description
defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first.
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Objective response (OR)
Description
defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.
Time Frame
Up to 30 months
Title
Duration of objective response (DOR)
Description
defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed objective response (based on blinded central independent review), whichever occurs first.
Time Frame
Up to 30 months
Title
Overall survival (OS)
Description
defined as the time interval from randomization until death from any cause
Time Frame
Up to 50 months
Title
Disease control (DC)
Description
defined as a best overall response of CR, PR, or stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (based on blinded central independent review).
Time Frame
Up to 30 months
Title
Change from baseline in QLQ-C30 (Quality of Life questionnaire C30)
Description
The QLQ C30 rates the overall quality of life in cancer participants. 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function, symptoms and financial difficulties and 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Includes scores for physical functioning, fatigue, pain, global health status.
Time Frame
Up to week 18
Title
Change from baseline in EQ-5D5L (European Quality of Life 5 dimensions 5 level)
Description
The EQ-5D-5L is a standardized instrument to assess of health outcome through 5 Likert scale items. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100.
Time Frame
Up to week 18
Title
Change from baseline in fatigue
Description
Fatigue symptoms are assessed through 25 items selected from the European Organization for Research and Treatment of Cancer (EORTC) item library. Items use a 4-point scale (1=not at all to 4=very much) similar to the C30.
Time Frame
Up to week 18
Title
Change from baseline in pain
Description
Pain symptoms are assessed through 18 items selected from the EORTC item library. Items use a 4-point scale (1=not at all to 4=very much) similar to the C30.
Time Frame
Up to week 18
Title
Occurrence of treatment-emergent adverse events (AEs)
Time Frame
Up to 30 months
Title
Occurrence of treatment-emergent AEs leading to study drug discontinuation
Time Frame
Up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF). Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information. Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial. Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available. Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review. Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis. Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt. Adequate organ function Exclusion Criteria: Known mutation in the TP53 gene (screening for TP53 status is not required). Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening. Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative). Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment. Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy). Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant). Further exclusion criteria apply
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Precision NextGen Oncology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Northern California Kaiser Permanente
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Harvard Medical School - Massachusetts General Hospital - Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abramson Cancer Center at Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Chris Obrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Princess Alexandra Hospital Division of Cancer Service
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Brussels - HOSP Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cross Cancer Institute (University of Alberta)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer Agency Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Cancer Hospital of Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing Municipality
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing Municipality
ZIP/Postal Code
100142
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
The First Afiliated Hospital, Sun Yet-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Harbin Medical University cancer hospital
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Hunan Province Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Migration Data
ZIP/Postal Code
100038
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai Municipality
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin Municipality
ZIP/Postal Code
300060
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Masaryk Memorial Cancer Institute
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
University Hospital Motol
City
Prague 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Comprehensive Cancer Center
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
FONK, Early Phase Oncology Research Unit
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
HOP Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CTR Eugène Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Institut Universitaire du Cancer Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Gustave Roussy,Cancer Campus
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Helios Klinikum Bad Saarow
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Essen AöR
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Asklepios Kliniken GmbH & Co. KGaA
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der Universität München - Campus Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus GmbH
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Hippokration General Hospital of Athen
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
"Attikon" University General Hospital of Attica
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Bioclinic Thessaloniki Oncology Clinic
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Istituto Nazionale IRCCS Tumori Fondazione Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituo Di Candiolo
City
Candiolo (TO)
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
AO Univ. Policlinico P.Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90129
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCSS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Humanitas Gavazzeni
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
AOU San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Nuovo Ospedale di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico Oncologia Medica
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi, Nagoya
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya University Hospital
City
Aichi, Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba, Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka, Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka, Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Hokkaido Cancer Center
City
Sapporo, Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo, Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Japanese Foundation for Cancer Research
City
Tokyo, Koto-ku
ZIP/Postal Code
N-0379
Country
Japan
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Antoni van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum Klinische Oncologie
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Oslo Universitetssykehus HF, Radiumhospitalet
City
Oslo
ZIP/Postal Code
135-8550
Country
Norway
Facility Name
Universitetssykehuset Nord-Norge, Tromsø
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
Facility Name
St. Luke Medical Centre
City
Quezon
ZIP/Postal Code
1102
Country
Philippines
Facility Name
IPO Lisboa Francisco Gentil, EPE
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
IPO Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Multidisciplinary Medical Center " Medicina24/7"
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
State Autonomus Healthcare Institution of Moscow "Moscow City Oncology Hospital #62 of Healthcare department of Moscow"
City
Moscow
ZIP/Postal Code
125130
Country
Russian Federation
Facility Name
JSC "Group of Companies "Medsi"
City
Moscow
ZIP/Postal Code
143442
Country
Russian Federation
Facility Name
BHI of Omsk region - Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Private Medical Institution "Euromedservice"
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
St. Petersburg S.B.H.I.City Oncology Dispensary
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sahlgrenska Universitetsjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skånes Universitetssjukhus
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Stockholm
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital(Linkou)
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
Facility Name
Baskent University Hospital
City
Adana
ZIP/Postal Code
01240
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi İç Hastalıklar Onkoloji
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Medipol University Medical Faculty
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Churchill Hospital
City
Headington
ZIP/Postal Code
OX3 9DS
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD Sharing Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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