Phase
Condition
Ovarian Cysts
Fallopian Tube Cancer
Treatment
Gemcitabine
Paclitaxel
Pegylated liposomal doxorubicin (PLD)
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants must have histologically or cytologically confirmed high grade serousor endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopiantube cancer.
Participants may be enrolled regardless of FRα expression level.
Participants must have received 1 to 4 prior lines of therapy. Participants musthave progressed radiographically on or after their most recent line of therapy.
Participants must have received prior treatment with the following therapies:
Platinum chemotherapy
Prior bevacizumab (or biosimilar) treatment is required, if labeled andavailable as standard of care per institutional guidelines, unless theparticipant has a documented contraindication or unless the participant is noteligible for treatment with bevacizumab (or biosimilar) due toprecautions/intolerance
Participants with known or suspected deleterious germline or somatic breastcancer gene (BRCA) mutations and who achieved a complete or partial response toplatinum-based chemotherapy must have been treated with a poly ADP-ribosepolymerase (PARP) inhibitor as maintenance treatment unless the participant isnot eligible for treatment with PARP inhibitor
Mirvetuximab soravtansine, if:
Mirvetuximab soravtansine is available in the enrollment region, and
The participant is eligible, and
The participant does not have a documented medical exception, includingchronic corneal disorders, history of corneal transplantation, or activeocular conditions requiring ongoing treatment/monitoring, such asuncontrolled glaucoma, wet age-related macular degeneration requiringintravitreal injections, active diabetic retinopathy with macular edema,macular degeneration, presence of papilledema, and /or monocular vision.
Participants must have platinum-resistant disease:
Participants who have only had 1 line of platinum-based therapy must havereceived at least 4 cycles of platinum therapy, and must have either had aresponse (CR or PR) or had non-measurable disease at the start of adjuvantplatinum-based therapy, and then progressed between > 91 days and ≤ 183 daysafter the date of the last dose of platinum.
Participants who have received a protocol defined number of lines ofplatinum-based therapy must have progressed on or within 183 days after thedate of the last dose of platinum.
Exclusion
Key Exclusion Criteria:
Prior therapy with an antibody-drug conjugate containing a topoisomerase 1inhibitor.
Have primary platinum-refractory disease, defined as ovarian cancer that did notrespond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-lineplatinum-containing regimen.
History of another malignancy within 3 years before the first dose of study drug, orany evidence of residual disease from a previously diagnosed malignancy. Exceptionsare malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of thecervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterinecancer.
Known active central nervous system metastases or carcinomatous meningitis.Participants with previously treated brain metastases may participate provided theyare clinically stable for at least 4 weeks prior to study entry after brainmetastasis treatment, they have no new or enlarging brain metastases, and are offcorticosteroids and anticonvulsants prescribed for symptoms associated with brainmetastases for at least 7 days prior to the first dose of study drug. Participantswith suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
Hospitalization or clinical symptoms due to gastrointestinal obstruction within thepast 91 days or radiographic evidence of gastrointestinal obstruction at the time ofscreening. Enrollment of participants who currently require parenteral nutritionmust be discussed with the study medical monitor to determine eligibility.
Participant has clinically significant ascites/pleural effusion. Enrollment ofparticipants with an indwelling catheter flush/drain is not allowed. Note:Clinically significant is defined as (1) symptomatic, or (2) requires therapeuticparacentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrentascites/pleural effusion that necessitates multiple paracentesis/thoracocentesisprocedures more often than approximately every 4 weeks.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Newcastle Private Hospital
New Lambton Heights, New South Wales
AustraliaSite Not Available
Icon Cancer Centre
South Brisbane, Queensland (qld) 4101
AustraliaSite Not Available
Icon Cancer Centre
South Brisbane 2207259, Queensland (qld) 4101
AustraliaSite Not Available
Mater Misericordiae - Mater Hospital Brisbane
South Brisbane,
AustraliaSite Not Available
Saint John of God - Subiaco Hospital
Subiaco, 6008
AustraliaSite Not Available
Medizinische Universität Innsbruck
Innsbruck, Tyrol 6020
AustriaSite Not Available
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Upper Austria (Oberösterreich) 4010
AustriaSite Not Available
Medizinische Universität Graz
Graz, 8036
AustriaSite Not Available
Krankenhaus Hietzing
Vienna, 1130
AustriaSite Not Available
Medizinische Universität Wien
Vienna, 1090
AustriaSite Not Available
Medizinische Universität Wien
Vienna 2761369, 1090
AustriaSite Not Available
Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
Turnhout, Antwerp 2300
BelgiumSite Not Available
AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
Aalst, 9300
BelgiumSite Not Available
Centre Hospitalier Universitaire Saint-Pierre
Brussels, 1000
BelgiumSite Not Available
Grand Hôpital de Charleroi - Site Les Viviers
Charleroi, 6000
BelgiumSite Not Available
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Centre Hospitalier Chretien - Clinique MontLégia
Liège, 4000
BelgiumSite Not Available
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, 051237111
BelgiumSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G2M9
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943 M5G2M9
CanadaSite Not Available
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec H2X0C1
CanadaSite Not Available
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, M4Y 3M5
CanadaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710049
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
Zhejiang Cancer Hospital
Hanzhou,
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, 200032
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
ChinaSite Not Available
Henan Cancer Hospital - Zhengzhou University
Zhengzhou,
ChinaSite Not Available
Masaryk Memorial Cancer Institute
Brno, 60200
CzechiaSite Not Available
Fakultní Nemocnice Hradec Králové
Hradec Králové, 50005
CzechiaSite Not Available
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, 74101
CzechiaSite Not Available
Bulovka University Hospital
Prague, 18000
CzechiaSite Not Available
Fakultni nemocnice v Motole
Prague, 15000
CzechiaSite Not Available
University Hospital Královské Vinohrady
Prague,
CzechiaSite Not Available
Vseobecna Fakultni Nemocnice v Praze
Prague, 12808
CzechiaSite Not Available
Bulovka University Hospital
Prague 3067696, 18000
CzechiaSite Not Available
Fakultni nemocnice v Motole
Prague 3067696, 15000
CzechiaSite Not Available
University Hospital Královské Vinohrady
Prague 3067696,
CzechiaActive - Recruiting
Vseobecna Fakultni Nemocnice v Praze
Prague 3067696, 12808
CzechiaSite Not Available
Aalborg Universitetshospital
Aalborg, 9000
DenmarkSite Not Available
The Royal Hospital (Rigshospitalet)
Copenhagen,
DenmarkSite Not Available
Odense Universitets Hospital
Odense, 5000
DenmarkSite Not Available
Centre Antoine Lacassagne
Nice, 6189
FranceSite Not Available
Hôpital Européen Georges-Pompidou
Paris, 75015
FranceSite Not Available
Hospital Lyon-Sud (HCL)
Pierre-Bénite, 69310
FranceSite Not Available
Centre Eugène Marquis
Rennes, 35042
FranceSite Not Available
Western Cancer Institute - Saint-Herblain - René Gauducheau Site
Saint-Herblain, 44800
FranceSite Not Available
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, 31059
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Helios Klinikum Berlin-Buch
Berlin, 13125
GermanySite Not Available
University Hospital Bonn
Bonn, 53127
GermanySite Not Available
University Hospital Carl Gustav Carus Dresden
Dresden, 01307
GermanySite Not Available
University Hospital of Düsseldorf
Düsseldorf, 40225
GermanySite Not Available
Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
Essen, 45136
GermanySite Not Available
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, 60596
GermanySite Not Available
Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
Giessen, 35392
GermanySite Not Available
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, 20357
GermanySite Not Available
MVZ Onko Medical GmbH Hanover
Hanover, 30449
GermanySite Not Available
University Hospital Heidelberg /Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
UniversitY Hospital of Saarland
Homburg, 66421
GermanySite Not Available
Red Cross Hospital Munich
Munich, 80634
GermanySite Not Available
Universitätsklinikum Münster/University Clinic Muenster
Münster, 48149
GermanySite Not Available
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199
GermanySite Not Available
General Hospital of Athens
Athens, 11527
GreeceSite Not Available
Attikon University General Hospital/General Hospital of West Attica
Chaïdári, 12462
GreeceSite Not Available
Aretaieio Hospital
Léfkos, 2024
GreeceSite Not Available
Saint Luke's Hospital
Panórama,
GreeceSite Not Available
Azienda Sanitaria Locale Brindisi
Brindisi, Apulia 72100
ItalySite Not Available
Humanitas San Pio X
Milan, 20159
ItalySite Not Available
Istituto Europeo di Oncologia/ European Institute of Oncology
Milan, 20141
ItalySite Not Available
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, 20132
ItalySite Not Available
Humanitas San Pio X
Milan 6951411, 20159
ItalySite Not Available
Local Health Authority of Biella - Nuovo Ospedale degli Infermi
Ponderano, 13875
ItalySite Not Available
Agostino Gemelli University Hospital Foundation IRCCS
Roma, 00168
ItalySite Not Available
Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
Torino, 10128
ItalySite Not Available
Aichi Cancer Center
Nagoya, Aichi Pref 4648681
JapanSite Not Available
Kurume University Hospital
Kurume, Fukuoka Pref 8300011
JapanSite Not Available
Hokkaido Cancer Center
Sapporo, Hokkaido 0300804
JapanSite Not Available
St. Marianna University Hospital
Kawasaki, Kanagawa Pref 2160015
JapanSite Not Available
Tohoku University Hospital
Sendai, Miyagi Pref 9808574
JapanSite Not Available
Niigata University Medical and Dental Hospital
Niigata, Niigata Pref 9518520
JapanSite Not Available
Okayama University Hospital
Okayama, Okayama Pref. 7008558
JapanSite Not Available
Saitama Medical University - International Medical Center
Hidaka 6822161, Saitama 1853226 350-1298
JapanActive - Recruiting
Saitama Medical University - International Medical Center
Hidaka, Saitama Pref. 350-1298
JapanSite Not Available
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka Pref. 4118777
JapanSite Not Available
Jichi Medical University Hospital
Saitama, Tochigi Pref. 329-0498
JapanSite Not Available
The Jikei University Hospital
Minato, Tokyo 105-0003
JapanSite Not Available
Ehime University Hospital
Shibukawa, Toon City, Ehime Pref 791-0295
JapanSite Not Available
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
JapanSite Not Available
National Cancer Center Hospital
Tokyo, 104-0045
JapanSite Not Available
Cancer Institute Hospital of JFCR
Tokyo 1850147, 135-8550
JapanSite Not Available
Amsterdam UMC, location VUmc
Amsterdam, 1081 HV
NetherlandsSite Not Available
Medisch Spectrum Twente - Enschede Koningsplein
Enschede, 7512 AV
NetherlandsSite Not Available
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333
NetherlandsSite Not Available
Maastricht (UMC) Universitair Medisch Centrum
Maastricht, 6229
NetherlandsSite Not Available
Erasmus MC/ Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
Oslo Universitetssykehus - Radiumhospitalet
Oslo, 0379
NorwaySite Not Available
University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
Tromsø, 9019
NorwaySite Not Available
Jagiellońskie Centrum Innowacj
Krakow, Lesser Poland (Małopolskie) 30-348
PolandSite Not Available
Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
Bialystok, 15-027
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, 80-211
PolandSite Not Available
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
PolandSite Not Available
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, 61-867
PolandSite Not Available
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
Siedlce, 08-110
PolandSite Not Available
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, 70-111
PolandSite Not Available
UPR Comprehensive Cancer Center Hospital
Monacillo, San Juan 00927
Puerto RicoSite Not Available
Hospital Universitario de A Coruña
A Coruña, 15006
SpainSite Not Available
Hospital Universitario DE Donostia
Donostia / San Sebastian, 20014
SpainSite Not Available
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, 30120
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28029
SpainSite Not Available
MD Anderson Cancer Center Madrid
Madrid, 28033
SpainSite Not Available
MD Anderson Cancer Center Madrid
Madrid 3117735, 28033
SpainSite Not Available
Virgen del Rocío University Hospital
Seville, 41013
SpainSite Not Available
IVO - Valencian Institute of Oncology Foundation
Valencia, 46009
SpainSite Not Available
Miguel Servet Hospital
Zaragoza, 50009
SpainSite Not Available
Alaska Women's Cancer Care
Anchorage, Alaska 99508
United StatesSite Not Available
Arizona Center for Cancer Care (ACCC) - Biltmore
Scottsdale, Arizona 85251
United StatesSite Not Available
University of Arizona Cancer Center - Research and Administration at Main Campus
Tucson, Arizona 85724
United StatesSite Not Available
Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
Burbank, California 91505
United StatesSite Not Available
University of California San Diego Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
USCF Mission Bay
San Francisco, California 94158
United StatesSite Not Available
Kaiser Permanente - Vallejo Medical Center
Vallejo, California 94589
United StatesSite Not Available
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut 06106
United StatesSite Not Available
Yale School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Norwalk Hospital
Norwalk, Connecticut 06850
United StatesSite Not Available
SCRI - Florida Cancer Specialists - South Region Research Office
Fort Myers, Florida 33901-8108
United StatesSite Not Available
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesSite Not Available
Orlando Health Cancer Institute - Downtown Orlando
Orlando, Florida 32806
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
SCRI - Florida Cancer Specialists - West Palm Beach
West Palm Beach, Florida 33401
United StatesSite Not Available
Northside Hospital Atlanta
Atlanta, Georgia 30342
United StatesSite Not Available
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Augusta University Georgia Cancer Center
Augusta, Georgia 30912
United StatesSite Not Available
Northside Hospital Atlanta
Atlanta 4180439, Georgia 4197000 30342
United StatesSite Not Available
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii 96826
United StatesSite Not Available
Northwest Cancer Center - Dyer
Dyer, Indiana 46311
United StatesSite Not Available
University of Kansas Cancer Center
Kansas City, Kansas 66160
United StatesSite Not Available
HCA Midwest Health
Overland Park, Kansas 66211
United StatesSite Not Available
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky 41017
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
Louisiana State University Health Sciences Center (LSU Health) - New Orleans
New Orleans, Louisiana 70112
United StatesSite Not Available
Trials365, LLC
Shreveport, Louisiana 71103
United StatesActive - Recruiting
Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
Shreveport, Louisiana 71103
United StatesSite Not Available
Maine Medical Center Cancer Institute- Scarborough
Scarborough, Maine 04074-7172
United StatesSite Not Available
Holy Cross Health - Holy Cross Hospital
Silver Spring, Maryland 20910
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Corewell Health (Spectrum Health)
Grand Rapids, Michigan 49503
United StatesSite Not Available
Saint Joseph Mercy Ann Arbor Hospital
Ypsilanti, Michigan 48197
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68105
United StatesSite Not Available
Center of Hope
Reno, Nevada 89511
United StatesSite Not Available
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesSite Not Available
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesSite Not Available
Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesSite Not Available
New York-Presbyterian - Weill Cornell Medical Center
New York, New York 10065
United StatesSite Not Available
Perlmutter Cancer Center - 38th Street
New York, New York 10016
United StatesSite Not Available
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York 10016
United StatesSite Not Available
James P. Wilmot Cancer Center
Rochester, New York 14642
United StatesSite Not Available
Herbert Irving Comprehensive Cancer Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Perlmutter Cancer Center - 38th Street
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Duke Cancer Institute
Durham, North Carolina 27705
United StatesSite Not Available
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina 28374
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic Main Campus
Cleveland, Ohio 44195
United StatesSite Not Available
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United StatesSite Not Available
MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Legacy Good Samaritan Medical Center
Portland, Oregon 97210
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon 97227
United StatesSite Not Available
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
Portland 5746545, Oregon 5744337 97227
United StatesSite Not Available
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Allegheny Health Network - West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Jefferson Health - Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
Abilene, Texas 79606
United StatesSite Not Available
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
Austin, Texas 78731
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
USOR - Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502
United StatesSite Not Available
Kadlec Clinic - Hematology and Oncology
Kennewick, Washington 99336
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesSite Not Available
Providence Sacred Heart Medical Center
Spokane, Washington 99204
United StatesSite Not Available
West Virginia University Cancer Institute
Morgantown, West Virginia 26506-9600
United StatesSite Not Available
University of Wisconsin - Madison
Madison, Wisconsin 53706
United StatesSite Not Available

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