Clinical trial NCT01493505: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Keywords: Primary Peritoneal Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 1015
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Incidence of adverse events and significant laboratory abnormalities
timeFrame: 4 years
measure: Pharmacokinetics of AMG 386 (Cmax and Cmin)
timeFrame: 1 year
measure: Incidence of anti-AMG 386 antibody formation
timeFrame: 4 years
measure: Patient reported ovarian cancer-specific symptoms and health related quality of life
timeFrame: 4 years
measure: Patient reported status as measured by the EuroQOL (EQ-5D)
timeFrame: 4 years
measure: AMG 386 exposure-response relationships for PFS and OS
timeFrame: 4 years
measure: Correlation of serum biomarkers with measures of response
timeFrame: 4 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Anchorage
country: United States
facility: Research Site
state: Alaska
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Berkeley
country: United States
facility: Research Site
state: California
city: Burbank
country: United States
facility: Research Site
state: California
city: Concord
country: United States
facility: Research Site
state: California
city: Corona
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Oxnard
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Farmington
country: United States
facility: Research Site
state: Connecticut
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: St Petersburg
country: United States
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state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Decatur
country: United States
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state: Illinois
city: Evanston
country: United States
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state: Illinois
city: Hinsdale
country: United States
facility: Research Site
state: Illinois
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Maywood
country: United States
facility: Research Site
state: Illinois
city: Oak Lawn
country: United States
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state: Illinois
city: Park Ridge
country: United States
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state: Illinois
city: Urbana
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Munster
country: United States
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state: Indiana
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Ames
country: United States
facility: Research Site
state: Iowa
city: Iowa City
country: United States
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state: Iowa
city: Kansas City
country: United States
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state: Kansas
city: Edgewood
country: United States
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state: Kentucky
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Covington
country: United States
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state: Louisiana
city: Lafayette
country: United States
facility: Research Site
state: Louisiana
city: Scarborough
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Burlington
country: United States
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state: Massachusetts
city: Danvers
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
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state: Minnesota
city: Rochester
country: United States
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state: Minnesota
city: St. Louis Park
country: United States
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state: Minnesota
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Kansas City
country: United States
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state: Missouri
city: St Louis
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Lebanon
country: United States
facility: Research Site
state: New Hampshire
city: Hackensack
country: United States
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state: New Jersey
city: Neptune
country: United States
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state: New Jersey
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Albuquerque
country: United States
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state: New Mexico
city: Albany
country: United States
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state: New York
city: Brightwaters
country: United States
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state: New York
city: Bronx
country: United States
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state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Jamaica
country: United States
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state: New York
city: Lake Success
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Burlington
country: United States
facility: Research Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Concord
country: United States
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state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
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state: North Carolina
city: Winston Salem
country: United States
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state: North Carolina
city: Winston Salem
country: United States
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state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Akron
country: United States
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state: Ohio
city: Canton
country: United States
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state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Kettering
country: United States
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state: Ohio
city: Mayfield Heights
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Bend
country: United States
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state: Oregon
city: Abington
country: United States
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state: Pennsylvania
city: Bethlehem
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Radnor
country: United States
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state: Pennsylvania
city: West Reading
country: United States
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state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Columbia
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
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state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Bedford
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Galveston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: The Woodlands
country: United States
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state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Annandale
country: United States
facility: Research Site
state: Virginia
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Roanoke
country: United States
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state: Virginia
city: Winchester
country: United States
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state: Virginia
city: Woodbridge
country: United States
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state: Virginia
city: Seattle
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Wenatchee
country: United States
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state: Washington
city: Green Bay
country: United States
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state: Wisconsin
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Marshfield
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Oshkosh
country: United States
facility: Research Site
state: Wisconsin
city: Sheboygan
country: United States
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state: Wisconsin
city: Waukesha
country: United States
facility: Research Site
state: Wisconsin
city: Wausau
country: United States
facility: Research Site
state: Wisconsin
city: West Allis
country: United States
facility: Research Site
state: Wisconsin
city: Graz
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Duffel
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Libramont
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: København Ø
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Konstanz
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Ravensburg
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Kowloon
country: Hong Kong
facility: Research Site
city: New Territories
country: Hong Kong
facility: Research Site
city: Avellino
country: Italy
facility: Research Site
city: Aviano PN
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Novara
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Nagoya-city
country: Japan
facility: Research Site
state: Aichi
city: Kashiwa
country: Japan
facility: Research Site
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-city
country: Japan
facility: Research Site
state: Fukuoka
city: Kure-city
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo-city
country: Japan
facility: Research Site
state: Hokkaido
city: Morioka-city
country: Japan
facility: Research Site
state: Iwate
city: Kitaadachi-gun
country: Japan
facility: Research Site
state: Saitama
city: Suntou-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Yonago-city
country: Japan
facility: Research Site
state: Tottori
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Deventer
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Girona
country: Spain
facility: Research Site
state: Cataluña
city: Lleida
country: Spain
facility: Research Site
state: Cataluña
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: El Palmar
country: Spain
facility: Research Site
state: Murcia
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.
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.