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SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients (CARMEN-LC03)

Primary Purpose

Non-small Cell Lung Cancer Metastatic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SAR408701
Docetaxel
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years of age or above (or country's legal age of maturity if above 18 years) and signed the informed consent.
  • Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
  • Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
  • At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • A female participant who agrees to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
  • A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.

Exclusion Criteria:

  • Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention.
  • Significant concomitant illnesses, including all severe medical conditions that would impair the patient's participation in the study or interpretation of the results.
  • History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
  • Non-resolution of any prior treatment related toxicity to less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
  • History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
  • Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
  • Concurrent treatment with any other anticancer therapy.
  • Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
  • Contraindication to use of corticosteroid premedication.
  • Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
  • Poor bone marrow, liver or kidney functions
  • Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sites / Locations

  • Arizona Oncology Associates-Site Number:8400024Recruiting
  • Comprehensive Blood and Cancer Center-Site Number:8400007Recruiting
  • National Jewish Health-Site Number:8400033Recruiting
  • Florida Cancer Specialists South Division-Site Number:8400020Recruiting
  • Florida Cancer Specialists North Division-Site Number:8400019Recruiting
  • Cancer Treatment Center of America(CTCA) - Southeastern-Site Number:8400015Recruiting
  • Ca & Hem Center Of W Michigan-Site Number:8400016Recruiting
  • Roswell Park Cancer Institute-Site Number:8400011Recruiting
  • Lankenau Hospital Cancer Center-Site Number:8400017Recruiting
  • Tennessee Oncology Nashville-Site Number:8400003Recruiting
  • Texas Oncology, PA-Site Number:8400028Recruiting
  • Texas Oncology, PA-Site Number:8400030Recruiting
  • Renovatio Clinical-Site Number:8400032Recruiting
  • Renovatio Clinical-Site Number:8400013Recruiting
  • Bon Secours St. Francis Medical Center-Site Number:8400035Recruiting
  • Medical College of Wisconsin-Site Number:8400006Recruiting
  • Investigational Site Number :0320009Recruiting
  • Investigational Site Number :0320012Recruiting
  • Investigational Site Number :0320008Recruiting
  • Investigational Site Number :0320003Recruiting
  • Investigational Site Number :0320005Recruiting
  • Investigational Site Number :0320001Recruiting
  • Investigational Site Number :0320004Recruiting
  • Investigational Site Number :0320014Recruiting
  • Investigational Site Number :0320002Recruiting
  • Investigational Site Number :0360002Recruiting
  • Investigational Site Number :0360003Recruiting
  • Investigational Site Number :0360001
  • Investigational Site Number :0560002Recruiting
  • Investigational Site Number :0560004Recruiting
  • Investigational Site Number :0560005Recruiting
  • Investigational Site Number :0560001Recruiting
  • Investigational Site Number :0560003Recruiting
  • Investigational Site Number :0760002Recruiting
  • Investigational Site Number :0760008Recruiting
  • Investigational Site Number :0760026Recruiting
  • Investigational Site Number :0760012Recruiting
  • Investigational Site Number :0760005Recruiting
  • Investigational Site Number :0760023Recruiting
  • Investigational Site Number :0760001Recruiting
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  • Investigational Site Number :6430003
  • Investigational Site Number :7240007Recruiting
  • Investigational Site Number :7240005Recruiting
  • Investigational Site Number :7240001Recruiting
  • Investigational Site Number :7240009Recruiting
  • Investigational Site Number :7240106Recruiting
  • Investigational Site Number :7240010Recruiting
  • Investigational Site Number :7240006Recruiting
  • Investigational Site Number :7240002Recruiting
  • Investigational Site Number :7240004Recruiting
  • Investigational Site Number :7240011Recruiting
  • Investigational Site Number :7240008Recruiting
  • Investigational Site Number :8260004Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAR408701 (tusamitamab ravtansine)

Docetaxel

Arm Description

Administered intravenously once every 2 weeks

Administered intravenously once every 3 weeks

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
PFS will be defined as the time from randomization to the date of the first documented disease progression or death of any cause, whichever comes first.
Overall Survival (OS)
OS will be defined as the time of randomization to the date of death due to any cause.

Secondary Outcome Measures

Objective response rate (ORR)
Objective response rate will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response derived from Overall Response (OR) determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
Health related quality of life (HRQOL) - disease related symptoms
Time to deterioration (TTD) in disease related symptoms as determined by European Organization for Research and Treatment for Cancer (EORTC)- Quality of life Questionnaire (QLQ)-Lung Cancer (LC)13
Health related quality of life (HRQOL) - physical function
TTD in physical function as determined by EORTC QLQ C30
Health related quality of life (HRQOL) - role function
TTD in role function as determined by EORTC QLQ C30
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI CTCAE V5
Duration of response (DOR)
Duration of response (DOR) is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first.

Full Information

First Posted
November 5, 2019
Last Updated
August 28, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04154956
Brief Title
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Acronym
CARMEN-LC03
Official Title
Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
July 11, 2024 (Anticipated)
Study Completion Date
August 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

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
Primary Objectives: Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) Study success is defined either on PFS or OS The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel To evaluate the safety of tusamitamab ravtansine compared to docetaxel To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
Detailed Description
The expected duration of study intervention for participants who benefit from study intervention may vary, based on progression date; but median expected duration of study per participant is estimated as median 9 months in docetaxel arm (1 month for screening, 4 months for treatment, and 4 months for the EOT and follow-up visits) and 12.5 months in SAR408701 arm (1 month for screening, 6.5 months for treatment, and 5 months for end of treatment follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Metastatic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SAR408701 (tusamitamab ravtansine)
Arm Type
Experimental
Arm Description
Administered intravenously once every 2 weeks
Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
Administered intravenously once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
SAR408701
Intervention Description
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
TAXOTERE
Intervention Description
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS will be defined as the time from randomization to the date of the first documented disease progression or death of any cause, whichever comes first.
Time Frame
Baseline to up to approximately 15 months
Title
Overall Survival (OS)
Description
OS will be defined as the time of randomization to the date of death due to any cause.
Time Frame
Baseline up to approximately 2 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response derived from Overall Response (OR) determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
Time Frame
Baseline up to approximately 2 years
Title
Health related quality of life (HRQOL) - disease related symptoms
Description
Time to deterioration (TTD) in disease related symptoms as determined by European Organization for Research and Treatment for Cancer (EORTC)- Quality of life Questionnaire (QLQ)-Lung Cancer (LC)13
Time Frame
Baseline up to median 12 months
Title
Health related quality of life (HRQOL) - physical function
Description
TTD in physical function as determined by EORTC QLQ C30
Time Frame
Baseline up to median 12 months
Title
Health related quality of life (HRQOL) - role function
Description
TTD in role function as determined by EORTC QLQ C30
Time Frame
Baseline up to median 12 months
Title
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Description
Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI CTCAE V5
Time Frame
Baseline up to end of study (approximately 2 years)
Title
Duration of response (DOR)
Description
Duration of response (DOR) is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first.
Time Frame
Baseline up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age or above (or country's legal age of maturity if above 18 years) and signed the informed consent. Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor. Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC). At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. A female participant who agrees to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention. A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention. Exclusion Criteria: Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention. Significant concomitant illnesses, including all severe medical conditions that would impair the patient's participation in the study or interpretation of the results. History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment. Non-resolution of any prior treatment related toxicity to less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted. Concurrent treatment with any other anticancer therapy. Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5. Contraindication to use of corticosteroid premedication. Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research. Poor bone marrow, liver or kidney functions Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates-Site Number:8400024
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Blood and Cancer Center-Site Number:8400007
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
National Jewish Health-Site Number:8400033
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists South Division-Site Number:8400020
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists North Division-Site Number:8400019
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Treatment Center of America(CTCA) - Southeastern-Site Number:8400015
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Recruiting
Facility Name
Ca & Hem Center Of W Michigan-Site Number:8400016
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Cancer Institute-Site Number:8400011
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Lankenau Hospital Cancer Center-Site Number:8400017
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096-3411
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology Nashville-Site Number:8400003
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology, PA-Site Number:8400028
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology, PA-Site Number:8400030
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
Renovatio Clinical-Site Number:8400032
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Individual Site Status
Recruiting
Facility Name
Renovatio Clinical-Site Number:8400013
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Bon Secours St. Francis Medical Center-Site Number:8400035
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin-Site Number:8400006
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320009
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1019ABS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320012
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320008
City
Pergamino
State/Province
Buenos Aires
ZIP/Postal Code
B2700CPM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320003
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320005
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
Buenos Aires
ZIP/Postal Code
1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320014
City
Ciudad De Cordoba
ZIP/Postal Code
ZCX5000AAI
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320002
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360002
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360003
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360001
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Completed
Facility Name
Investigational Site Number :0560002
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560004
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560005
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560003
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760002
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760008
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80530-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760026
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760012
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760005
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760023
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760001
City
Sao Jose do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760010
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01236030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760018
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01308050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760024
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760022
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760007
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760025
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000008
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000010
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000007
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000004
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000002
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000003
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000005
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240008
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240010
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1P7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240009
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520005
City
Temuco
State/Province
La Araucanía
ZIP/Postal Code
4810561
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520007
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500713
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520006
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520004
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520009
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7650568
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560042
City
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560026
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560029
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560027
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560030
City
Beijing
ZIP/Postal Code
100210
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560009
City
Changchun
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560010
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560015
City
Changsha
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560039
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560032
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560038
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560044
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560043
City
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560024
City
Fuzhou
ZIP/Postal Code
350008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :1560051
City
Ganzhou
ZIP/Postal Code
341099
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560036
City
Guangzhou
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560037
City
Guangzhou
ZIP/Postal Code
510163
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560017
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560034
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560025
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560033
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560021
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560018
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560011
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560005
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560014
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560004
City
Hefei
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560050
City
Huizhou
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560047
City
Jinan
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560028
City
Jinan
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560035
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560023
City
Nanjing
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560019
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560012
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560045
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560006
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560016
City
Zhanjiang
ZIP/Postal Code
524001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560041
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560040
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560048
City
Zhongshan
ZIP/Postal Code
528403
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500010
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500008
City
CAEN Cedex 05
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500006
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500005
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500007
City
GRENOBLE Cedex 9
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500001
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500013
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500011
City
Paris
ZIP/Postal Code
75231
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500014
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500009
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
RENNES Cedex 09
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500012
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500002
City
Saint-mande
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500004
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760002
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760001
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760003
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000005
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000003
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000004
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000002
City
Larissa
ZIP/Postal Code
41500
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000006
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480003
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480004
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480007
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480005
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760001
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760002
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760003
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800004
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800007
City
Aviano (PN)
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800005
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800003
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800006
City
Catania
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800001
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920015
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920012
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920016
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920017
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920005
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920009
City
Natori-shi
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920013
City
Osaka Sayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920014
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920011
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920018
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920007
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100005
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100006
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100007
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100003
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100004
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100008
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100001
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4400003
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4400001
City
Vilnius
ZIP/Postal Code
1 08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840003
City
Cuauhtémoc
State/Province
Ciudad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840004
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840008
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280003
City
's Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280004
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280005
City
Utrecht
ZIP/Postal Code
3543 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160004
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200002
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200001
City
Lisboa
ZIP/Postal Code
1769
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200004
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200005
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200006
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420008
City
Alba Iulia
ZIP/Postal Code
510077
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420009
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420003
City
Bucaresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420002
City
Bucuresti
ZIP/Postal Code
10991
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420010
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420011
City
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420006
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420012
City
Otopeni
ZIP/Postal Code
75100
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420005
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420004
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430003
City
Saint -Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :7240007
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240005
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Hospitalet de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240009
City
Madrid / Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240106
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240010
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240006
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240011
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240008
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260004
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR13LJ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

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