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TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AMG 386
Paclitaxel
AMG 386 Placebo
Carboplatin
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring Primary Peritoneal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
  • Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
  • Subjects with FIGO Stage IIIC or IV disease must either:
  • Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
  • Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

  • Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Previous abdominal and/or pelvic external beam radiotherapy
  • History of central nervous metastasis
  • History of arterial or venous thromboembolism within 12 months prior to randomization
  • Clinically significant cardiovascular disease within 12 months prior to randomization

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

AMG 386

Arm Description

Placebo Paclitaxel Carboplatin

AMG 386 Paclitaxel Carboplatin

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival (OS)
Incidence of adverse events and significant laboratory abnormalities
Pharmacokinetics of AMG 386 (Cmax and Cmin)
pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
Incidence of anti-AMG 386 antibody formation
pre-dose weeks 1, 10, 19
Patient reported ovarian cancer-specific symptoms and health related quality of life
Patient reported status as measured by the EuroQOL (EQ-5D)
AMG 386 exposure-response relationships for PFS and OS
Correlation of serum biomarkers with measures of response

Full Information

First Posted
September 29, 2011
Last Updated
February 22, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01493505
Brief Title
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Official Title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Amgen Administrative Decision - termination of LTFU
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Keywords
Primary Peritoneal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1015 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Paclitaxel Carboplatin
Arm Title
AMG 386
Arm Type
Active Comparator
Arm Description
AMG 386 Paclitaxel Carboplatin
Intervention Type
Drug
Intervention Name(s)
AMG 386
Intervention Description
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Intervention Type
Drug
Intervention Name(s)
AMG 386 Placebo
Intervention Description
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
5 years
Title
Incidence of adverse events and significant laboratory abnormalities
Time Frame
4 years
Title
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Description
pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
Time Frame
1 year
Title
Incidence of anti-AMG 386 antibody formation
Description
pre-dose weeks 1, 10, 19
Time Frame
4 years
Title
Patient reported ovarian cancer-specific symptoms and health related quality of life
Time Frame
4 years
Title
Patient reported status as measured by the EuroQOL (EQ-5D)
Time Frame
4 years
Title
AMG 386 exposure-response relationships for PFS and OS
Time Frame
4 years
Title
Correlation of serum biomarkers with measures of response
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization Subjects with FIGO Stage IIIC or IV disease must either: Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer ECOG performance status of 0 or 1 Adequate bone marrow, renal and hepatic function Exclusion Criteria: Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer Previous abdominal and/or pelvic external beam radiotherapy History of central nervous metastasis History of arterial or venous thromboembolism within 12 months prior to randomization Clinically significant cardiovascular disease within 12 months prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Research Site
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Research Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
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Research Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
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United States
Facility Name
Research Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
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United States
Facility Name
Research Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
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United States
Facility Name
Research Site
City
Corona
State/Province
California
ZIP/Postal Code
92879
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United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0957
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United States
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Research Site
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Long Beach
State/Province
California
ZIP/Postal Code
90806
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United States
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Research Site
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Los Angeles
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California
ZIP/Postal Code
90027
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United States
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Research Site
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Orange
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California
ZIP/Postal Code
92868
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United States
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Research Site
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Oxnard
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California
ZIP/Postal Code
93030
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United States
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Research Site
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Rancho Mirage
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California
ZIP/Postal Code
92270
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United States
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Research Site
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Sacramento
State/Province
California
ZIP/Postal Code
95816
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United States
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Research Site
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Sacramento
State/Province
California
ZIP/Postal Code
95817
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United States
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Research Site
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San Diego
State/Province
California
ZIP/Postal Code
92123
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United States
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Research Site
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Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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United States
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Research Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
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United States
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Research Site
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Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
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United States
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Research Site
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Farmington
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Connecticut
ZIP/Postal Code
06030
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United States
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Research Site
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Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
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United States
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Research Site
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New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
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United States
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Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
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United States
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Research Site
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Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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United States
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Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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United States
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Research Site
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Miami
State/Province
Florida
ZIP/Postal Code
33146
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United States
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Research Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32804
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United States
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Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
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Research Site
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St Petersburg
State/Province
Florida
ZIP/Postal Code
33701
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United States
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Research Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33612
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United States
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Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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United States
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Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
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United States
Facility Name
Research Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
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United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
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United States
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
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Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Research Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
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United States
Facility Name
Research Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
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United States
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Research Site
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
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United States
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Research Site
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Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
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United States
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Research Site
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
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United States
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Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Research Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46628
Country
United States
Facility Name
Research Site
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Research Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Research Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Research Site
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Research Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Site
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Research Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Research Site
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Research Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Research Site
City
Brightwaters
State/Province
New York
ZIP/Postal Code
11718
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Research Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Research Site
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7570
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402
Country
United States
Facility Name
Research Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0457
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Research Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Research Site
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Research Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Research Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Research Site
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Research Site
City
Radnor
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Facility Name
Research Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9032
Country
United States
Facility Name
Research Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Research Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Research Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Research Site
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Research Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Research Site
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22191
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Research Site
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Research Site
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Research Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Research Site
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54904
Country
United States
Facility Name
Research Site
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Research Site
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Research Site
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Research Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Research Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Research Site
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Research Site
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Research Site
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Research Site
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Research Site
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Research Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Research Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Research Site
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Research Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Research Site
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30177
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Research Site
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Research Site
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Research Site
City
Stuttgart
ZIP/Postal Code
70374
Country
Germany
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Patra
ZIP/Postal Code
26500
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Kowloon
Country
Hong Kong
Facility Name
Research Site
City
New Territories
Country
Hong Kong
Facility Name
Research Site
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Research Site
City
Aviano PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90126
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Nagoya-city
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8567
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Research Site
City
Kurume-city
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Research Site
City
Kure-city
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Research Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Research Site
City
Morioka-city
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Research Site
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Research Site
City
Suntou-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Research Site
City
Yonago-city
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Research Site
City
Goyang-si, Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
Research Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Research Site
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Research Site
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Research Site
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Research Site
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Girona
State/Province
Cataluña
ZIP/Postal Code
17007
Country
Spain
Facility Name
Research Site
City
Lleida
State/Province
Cataluña
ZIP/Postal Code
25198
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27029706
Citation
Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.
Results Reference
background
PubMed Identifier
31076365
Citation
Vergote I, Scambia G, O'Malley DM, Van Calster B, Park SY, Del Campo JM, Meier W, Bamias A, Colombo N, Wenham RM, Covens A, Marth C, Raza Mirza M, Kroep JR, Ma H, Pickett CA, Monk BJ; TRINOVA-3/ENGOT-ov2/GOG-3001 investigators. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):862-876. doi: 10.1016/S1470-2045(19)30178-0. Epub 2019 May 7.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

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