Trial record 1 of 1 for:    NCT01493505
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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

This study is currently recruiting participants.
Verified February 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01493505
First received: September 29, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Drug: AMG 386
Drug: Paclitaxel
Drug: AMG 386 Placebo
Drug: Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7

  • Incidence of anti-AMG 386 antibody formation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    pre-dose weeks 1, 10, 19

  • Patient reported ovarian cancer-specific symptoms and health related quality of life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Patient reported status as measured by the EuroQOL (EQ-5D) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • AMG 386 exposure-response relationships for PFS and OS [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Correlation of serum biomarkers with measures of response [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Drug: AMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Drug: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Active Comparator: AMG 386 Drug: AMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Drug: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Drug: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493505

Contacts
Contact: Amgen Call Center 866-572-6436

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Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States, 35233
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Mobile, Alabama, United States, 36604
United States, Alaska
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Anchorage, Alaska, United States, 99508
United States, Arizona
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Gilbert, Arizona, United States, 85234
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85016
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Phoenix, Arizona, United States, 85013
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Tucson, Arizona, United States, 85710
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Tucson, Arizona, United States, 85724-5024
United States, California
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Berkeley, California, United States, 94704
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Burbank, California, United States, 91505
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Concord, California, United States, 94520
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Corona, California, United States, 92879
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La Jolla, California, United States, 92093-0957
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Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90027
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Orange, California, United States, 92868
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Oxnard, California, United States, 93030
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Rancho Mirage, California, United States, 92270
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Sacramento, California, United States, 95816
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Sacramento, California, United States, 95817
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San Diego, California, United States, 92123
United States, Colorado
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Aurora, Colorado, United States, 80045
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Englewood, Colorado, United States, 80113
United States, Connecticut
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Bridgeport, Connecticut, United States, 06606
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Farmington, Connecticut, United States, 06030
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Hartford, Connecticut, United States, 06106
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New Britain, Connecticut, United States, 06050
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Stamford, Connecticut, United States, 06902
United States, Florida
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Clearwater, Florida, United States, 33756
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Hollywood, Florida, United States, 33021
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Miami, Florida, United States, 33146
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Orlando, Florida, United States, 32806
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Orlando, Florida, United States, 32804
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St Petersburg, Florida, United States, 33701
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Tampa, Florida, United States, 33612
United States, Georgia
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Augusta, Georgia, United States, 30912
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Gainesville, Georgia, United States, 30501
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Macon, Georgia, United States, 31201
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Savannah, Georgia, United States, 31404
United States, Hawaii
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Honolulu, Hawaii, United States, 96826
United States, Illinois
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60611
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Decatur, Illinois, United States, 62526
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Evanston, Illinois, United States, 60201
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Hinsdale, Illinois, United States, 60521
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Joliet, Illinois, United States, 60435
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Maywood, Illinois, United States, 60153
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Oak Lawn, Illinois, United States, 60453
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Park Ridge, Illinois, United States, 60068
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Urbana, Illinois, United States, 61801
United States, Indiana
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Indianapolis, Indiana, United States, 46237
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Indianapolis, Indiana, United States, 46202
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Indianapolis, Indiana, United States, 46260
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Munster, Indiana, United States, 46321
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South Bend, Indiana, United States, 46601
United States, Iowa
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Ames, Iowa, United States, 50010
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Iowa City, Iowa, United States, 52242
United States, Kansas
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Kansas City, Kansas, United States, 66160
United States, Kentucky
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Edgewood, Kentucky, United States, 41017
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Lexington, Kentucky, United States, 40536
United States, Louisiana
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Covington, Louisiana, United States, 70433
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Lafayette, Louisiana, United States, 70503
United States, Maine
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Scarborough, Maine, United States, 04074
United States, Maryland
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Baltimore, Maryland, United States, 21237
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Baltimore, Maryland, United States, 21204
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Baltimore, Maryland, United States, 21215
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Burlington, Massachusetts, United States, 01805
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Danvers, Massachusetts, United States, 01923
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Worcester, Massachusetts, United States, 01605
United States, Michigan
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Detroit, Michigan, United States, 48202
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Detroit, Michigan, United States, 48201
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Kalamazoo, Michigan, United States, 49007
United States, Minnesota
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Minneapolis, Minnesota, United States, 55416
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Rochester, Minnesota, United States, 55905
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St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
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Jackson, Mississippi, United States, 39216
United States, Missouri
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Kansas City, Missouri, United States, 64111
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St Louis, Missouri, United States, 63110
United States, Montana
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Billings, Montana, United States, 59101
United States, Nebraska
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Lincoln, Nebraska, United States, 68506
United States, Nevada
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Las Vegas, Nevada, United States, 89169
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Reno, Nevada, United States, 89502
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
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Neptune, New Jersey, United States, 07753
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Voorhees, New Jersey, United States, 08043
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
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Albuquerque, New Mexico, United States, 87131
United States, New York
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Albany, New York, United States, 12208
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Brightwaters, New York, United States, 11718
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Bronx, New York, United States, 10461
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Buffalo, New York, United States, 14263
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Jamaica, New York, United States, 11432
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Lake Success, New York, United States, 11042
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New York, New York, United States, 10029
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New York, New York, United States, 10032
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New York, New York, United States, 10065
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Syracuse, New York, United States, 13210
United States, North Carolina
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Asheville, North Carolina, United States, 28806
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Burlington, North Carolina, United States, 27215
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Chapel Hill, North Carolina, United States, 27599-7570
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Charlotte, North Carolina, United States, 28204
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Concord, North Carolina, United States, 28025
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Durham, North Carolina, United States, 27710
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Wilmington, North Carolina, United States, 28402
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Winston Salem, North Carolina, United States, 27103
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Winston Salem, North Carolina, United States, 27157
United States, North Dakota
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Fargo, North Dakota, United States, 58122
United States, Ohio
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Akron, Ohio, United States, 44304
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Canton, Ohio, United States, 44710
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Cincinnati, Ohio, United States, 45267-0457
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Cincinnati, Ohio, United States, 45220
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Cleveland, Ohio, United States, 44106
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Cleveland, Ohio, United States, 44109
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Cleveland, Ohio, United States, 44195
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Columbus, Ohio, United States, 43210
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Columbus, Ohio, United States, 43214
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Kettering, Ohio, United States, 45429
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Mayfield Heights, Ohio, United States, 44124
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Toledo, Ohio, United States, 43614
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
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Tulsa, Oklahoma, United States, 74136
United States, Oregon
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Bend, Oregon, United States, 97701
United States, Pennsylvania
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Abington, Pennsylvania, United States, 19001
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Bethlehem, Pennsylvania, United States, 18015
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15213
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Pittsburgh, Pennsylvania, United States, 15224
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Radnor, Pennsylvania, United States, 19087
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West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
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Providence, Rhode Island, United States, 02905
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29210
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Greenville, South Carolina, United States, 29605
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Greenville, South Carolina, United States, 29601
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
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Chattanooga, Tennessee, United States, 37403
United States, Texas
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Austin, Texas, United States, 78731
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Austin, Texas, United States, 78701
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Bedford, Texas, United States, 76022
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75390-9032
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Dallas, Texas, United States, 75246
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Galveston, Texas, United States, 77555
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78217
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The Woodlands, Texas, United States, 77380
United States, Utah
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Ogden, Utah, United States, 84403
United States, Vermont
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Burlington, Vermont, United States, 05401
United States, Virginia
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Annandale, Virginia, United States, 22003
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Charlottesville, Virginia, United States, 22903
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Norfolk, Virginia, United States, 23502
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Roanoke, Virginia, United States, 24016
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Winchester, Virginia, United States, 22601
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Woodbridge, Virginia, United States, 22191
United States, Washington
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Seattle, Washington, United States, 98104
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Tacoma, Washington, United States, 98405
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Wenatchee, Washington, United States, 98801
United States, Wisconsin
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Green Bay, Wisconsin, United States, 54311
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Green Bay, Wisconsin, United States, 54301
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Marshfield, Wisconsin, United States, 54449
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Milwaukee, Wisconsin, United States, 53215
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Milwaukee, Wisconsin, United States, 53233
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Milwaukee, Wisconsin, United States, 53226
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Oshkosh, Wisconsin, United States, 54904
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Sheboygan, Wisconsin, United States, 53081
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Waukesha, Wisconsin, United States, 53188
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Wausau, Wisconsin, United States, 54401
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West Allis, Wisconsin, United States, 53227
Austria
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Graz, Austria, 8036
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Graz, Austria, 8020
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Innsbruck, Austria, 6020
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Linz, Austria, 4010
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Linz, Austria, 4020
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Salzburg, Austria, 5020
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Wien, Austria, 1130
Belgium
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Bonheiden, Belgium, 2820
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Brasschaat, Belgium, 2930
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Bruxelles, Belgium, 1000
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Charleroi, Belgium, 6000
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Duffel, Belgium, 2570
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Hasselt, Belgium, 3500
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Libramont, Belgium, 6800
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Liège, Belgium, 4000
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Namur, Belgium, 5000
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Oostende, Belgium, 8400
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Sint-Niklaas, Belgium, 9100
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Turnhout, Belgium, 2300
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Wilrijk, Belgium, 2610
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Yvoir, Belgium, 5530
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Kingston, Ontario, Canada, K7L 5P9
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London, Ontario, Canada, N6A 4L6
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Sault Ste. Marie, Ontario, Canada, P6B 0A8
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
Canada
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Quebec, Canada, G1R 2J6
Denmark
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Herlev, Denmark, 2730
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København Ø, Denmark, 2100
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Roskilde, Denmark, 4000
Germany
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Berlin, Germany, 13353
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Dresden, Germany, 01307
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Düsseldorf, Germany, 40217
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Düsseldorf, Germany, 40225
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Erlangen, Germany, 91054
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Essen, Germany, 45147
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Essen, Germany, 45136
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Frankfurt am Main, Germany, 65929
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Frankfurt am Main, Germany, 60590
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Freiburg, Germany, 79106
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Hamburg, Germany, 20246
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Hannover, Germany, 30625
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Hannover, Germany, 30177
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Kiel, Germany, 24105
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Konstanz, Germany, 78464
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Leipzig, Germany, 04103
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Ludwigsburg, Germany, 71640
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München, Germany, 81675
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München, Germany, 81377
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München, Germany, 80337
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Oldenburg, Germany, 26121
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Ravensburg, Germany, 88212
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Rostock, Germany, 18059
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Stuttgart, Germany, 70374
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Tübingen, Germany, 72076
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Ulm, Germany, 89075
Greece
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Athens, Greece, 11527
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Athens, Greece, 11528
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Athens, Greece, 14564
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Athens, Greece, 11522
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Larissa, Greece, 41110
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Patra, Greece, 26500
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Thessaloniki, Greece, 56429
Hong Kong
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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New Territories, Hong Kong
Italy
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Avellino, Italy, 83100
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Aviano PN, Italy, 33081
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Bari, Italy, 70124
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Bologna, Italy, 40138
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Brescia, Italy, 25123
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Genova, Italy, 16132
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Milano, Italy, 20133
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Milano, Italy, 20141
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Napoli, Italy, 80131
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Novara, Italy, 28100
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Palermo, Italy, 90126
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Pisa, Italy, 56126
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Roma, Italy, 00168
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Roma, Italy, 00144
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Torino, Italy, 10126
Japan
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Nagoya-city, Aichi, Japan, 464-8681
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Kashiwa, Chiba, Japan, 277-8567
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Fukuoka-shi, Fukuoka, Japan, 811-1395
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Kurume-city, Fukuoka, Japan, 830-0011
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Kure-city, Hiroshima, Japan, 737-0023
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Sapporo-city, Hokkaido, Japan, 003-0804
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Morioka-city, Iwate, Japan, 020-8505
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Kitaadachi-gun, Saitama, Japan, 362-0806
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Suntou-gun, Shizuoka, Japan, 411-8777
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Yonago-city, Tottori, Japan, 683-8504
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Tokyo, Japan, 105-8471
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Tokyo, Japan, 160-8582
Korea, Republic of
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Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 135-710
Netherlands
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Deventer, Netherlands, 7416 SE
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Leiden, Netherlands, 2333 ZA
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3015 CE
Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Ivanovo, Russian Federation, 153013
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Krasnodar, Russian Federation, 350040
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Moscow, Russian Federation, 115478
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Obninsk, Russian Federation, 249036
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Pyatigorsk, Russian Federation, 357502
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Saint Petersburg, Russian Federation, 197022
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Ufa, Russian Federation, 450054
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Voronezh, Russian Federation, 394000
Spain
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Zaragoza, Aragón, Spain, 50009
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Oviedo, Asturias, Spain, 33006
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Palma de Mallorca, Baleares, Spain, 07198
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Badalona, Cataluña, Spain, 08916
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Barcelona, Cataluña, Spain, 08035
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Girona, Cataluña, Spain, 17007
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Lleida, Cataluña, Spain, 25198
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Valencia, Comunidad Valenciana, Spain, 46009
Research Site Completed
Valencia, Comunidad Valenciana, Spain, 46026
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Valencia, Comunidad Valenciana, Spain, 46014
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El Palmar, Murcia, Spain, 30120
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Madrid, Spain, 28033
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Madrid, Spain, 28009
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Madrid, Spain, 28034
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Madrid, Spain, 28046
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Madrid, Spain, 28040
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Madrid, Spain, 28922
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Madrid, Spain, 28041
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Madrid, Spain, 28050
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01493505     History of Changes
Other Study ID Numbers: 20101129, TRINOVA-3 20101129/ENGOT-ov2
Study First Received: September 29, 2011
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Primary Peritoneal Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 21, 2014