Back to resultsDurvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer (DUO-E)
Primary Purpose
Endometrial Neoplasms
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olaparib
durvalumab
durvalumab placebo
olaparib placebo
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Neoplasms focused on measuring Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Cancer, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years at the time of screening and female.
- Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
Patient must have endometrial cancer in one of the following categories:
- Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
- Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
- Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
- Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse
- FPPE tumor sample must be available for MMR evaluation.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.
Exclusion Criteria:
- History of leptomeningeal carcinomatosis.
- Brain metastases or spinal cord compression.
- Prior treatment with PARP inhibitors.
- Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm A (control)
Arm B (durvalumab+placebo)
Arm C (durvalumab+olaparib)
Arm Description
Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A
Defined as the time from randomisation until the date of objective disease progression (per RECIST 1.1 as assessed by investigator) or death (by any cause in the absence of progression)
Secondary Outcome Measures
Second Progression (PFS2)
Defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause
Overall Survival (OS)
Defined as the time from randomisation to death due to any cause
Objective Response Rate (ORR)
Defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site.
Duration of response (DoR)
Defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression
Time to first subsequent therapy (TFST)
Defined as the time from randomisation to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment or death due to any cause
Time to second subsequent therapy (TSST)
Defined as the time from randomisation to the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment or death due to any cause.
Time to discontinuation or death (TDT)
Defined as the time from randomisation to the earlier of the date of study treatment discontinuation or death.
The pharmacokinetics (PK) of durvalumab will be determined after steady state doses
Determination of durvalumab concentration in serum
Safety and tolerability of drugs by assessment of AEs/SAEs
Graded according to the National Cancer Institute (NCI CTCAE)
The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab
Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum
Full Information
NCT ID
NCT04269200
First Posted
February 10, 2020
Last Updated
December 14, 2022
Sponsor
AstraZeneca
Collaborators
The Gynecologic Oncology Group (GOG) Foundation Inc, The European Network for Gynaecological Oncological Trial groups (ENGOT)
1. Study Identification
Unique Protocol Identification Number
NCT04269200
Brief Title
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
Acronym
DUO-E
Official Title
A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
September 26, 2023 (Anticipated)
Study Completion Date
March 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
The Gynecologic Oncology Group (GOG) Foundation Inc, The European Network for Gynaecological Oncological Trial groups (ENGOT)
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
A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Detailed Description
This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms
Keywords
Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Cancer, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
699 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A (control)
Arm Type
Active Comparator
Arm Description
Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
Arm Title
Arm B (durvalumab+placebo)
Arm Type
Experimental
Arm Description
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
Arm Title
Arm C (durvalumab+olaparib)
Arm Type
Experimental
Arm Description
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.
Intervention Type
Drug
Intervention Name(s)
olaparib
Intervention Description
Olaparib tablets
Intervention Type
Biological
Intervention Name(s)
durvalumab
Intervention Description
Durvalumab by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
durvalumab placebo
Intervention Description
Matching placebo for intravenous infusion
Intervention Type
Drug
Intervention Name(s)
olaparib placebo
Intervention Description
Placebo tablets to match olaparib
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Standard of care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Standard of care chemotherapy
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A
Description
Defined as the time from randomisation until the date of objective disease progression (per RECIST 1.1 as assessed by investigator) or death (by any cause in the absence of progression)
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Second Progression (PFS2)
Description
Defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause
Time Frame
Up to 6 years
Title
Overall Survival (OS)
Description
Defined as the time from randomisation to death due to any cause
Time Frame
Up to 6 years
Title
Objective Response Rate (ORR)
Description
Defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site.
Time Frame
Up to 4 years
Title
Duration of response (DoR)
Description
Defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression
Time Frame
Up to 4 years
Title
Time to first subsequent therapy (TFST)
Description
Defined as the time from randomisation to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment or death due to any cause
Time Frame
Up to 6 years
Title
Time to second subsequent therapy (TSST)
Description
Defined as the time from randomisation to the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment or death due to any cause.
Time Frame
Up to 6 years
Title
Time to discontinuation or death (TDT)
Description
Defined as the time from randomisation to the earlier of the date of study treatment discontinuation or death.
Time Frame
Up to 6 years
Title
The pharmacokinetics (PK) of durvalumab will be determined after steady state doses
Description
Determination of durvalumab concentration in serum
Time Frame
Up to 4 years
Title
Safety and tolerability of drugs by assessment of AEs/SAEs
Description
Graded according to the National Cancer Institute (NCI CTCAE)
Time Frame
Up to 6 years
Title
The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab
Description
Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum
Time Frame
Up to 4 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female subjects only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
150 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at the time of screening and female.
Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
Patient must have endometrial cancer in one of the following categories:
Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse
FPPE tumor sample must be available for MMR evaluation.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.
Exclusion Criteria:
History of leptomeningeal carcinomatosis.
Brain metastases or spinal cord compression.
Prior treatment with PARP inhibitors.
Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon N. Westin, MD, MPH, FACOG
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Concord
State/Province
California
ZIP/Postal Code
94520-2278
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74134
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Campbelltown
ZIP/Postal Code
2560
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sydney
ZIP/Postal Code
NSW 2145
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Libramont-Chevigny
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30150-274
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80520-174
Country
Brazil
Individual Site Status
Terminated
Facility Name
Research Site
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Pelotas
ZIP/Postal Code
96020-080
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Terminated
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01317-001
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Terminated
Facility Name
Research Site
City
Chicoutimi
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dalian
ZIP/Postal Code
116001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dalian
ZIP/Postal Code
116027
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhanjiang
ZIP/Postal Code
524001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
110321
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
111411
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Cali
ZIP/Postal Code
760043
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cali
ZIP/Postal Code
760043
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
50030
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Medellín
Country
Colombia
Individual Site Status
Terminated
Facility Name
Research Site
City
Monteria
ZIP/Postal Code
23001
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Pereira
ZIP/Postal Code
660001
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Rionegro
ZIP/Postal Code
54048
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
1131
Country
Estonia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Terminated
Facility Name
Research Site
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
65929
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Marousi
ZIP/Postal Code
151 23
Country
Greece
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
HKG
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tun Mun
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560017
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560027
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hisar
ZIP/Postal Code
125005
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Mysuru
ZIP/Postal Code
570021
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nagpur
ZIP/Postal Code
440003
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422005
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110075
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411004
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Be'er Ya'akov
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kashiwa-shi
ZIP/Postal Code
277-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Matsuyama-shi
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
105-8471
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Nakagami-gun
ZIP/Postal Code
903-0215
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Osaka
ZIP/Postal Code
637086
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Toon-Shi
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Tsu-shi
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
01812
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
443380
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Yangsan-si
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
8660
Country
Lithuania
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Ciudad de Mexico
ZIP/Postal Code
01120
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Terminated
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-560
Country
Poland
Individual Site Status
Terminated
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Anzorey
ZIP/Postal Code
361350
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kazan, Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Moskva
ZIP/Postal Code
115682
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sochi
ZIP/Postal Code
354000
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
329563
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
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