A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Start Date
2/17/2022
Completion Date
6/30/2027
Summary
This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
Detailed Description
A Phase 2 study to evaluate the efficacy and safety of azenossertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage leading to mitotic catastrophe and cancer cell death. The study consists of two parts: Part 1: All comers, no biomarker status required (completed enrollment) Part 2: Cyclin E1 positive protein expression required
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
azenosertib
Conditions
Locations
Site 0170-USA Mitchell Cancer Institute
Mobile, Alabama 36604
United States
Site 0143 - HonorHealth
Phoenix, Arizona 85016
United States
Site 0102 - University of Arizona Cancer Center
Tucson, Arizona 85724
United States
Site 0258 - UC San Diego Moores Cancer Center
La Jolla, California 92037
United States
Site 0287 - Ridley Tree Cancer Center
Santa Barbara, California 93105
United States
Site 0135 - Rocky Mountain Cancer Centers
Lone Tree, Colorado 80218
United States
Site 0158 - Hartford HealthCare
Hartford, Connecticut 06106
United States
Site 0239 - Florida Cancer Specialists - East
Daytona Beach, Florida 32117
United States
Site 0241 - Florida Cancer Specialist - North
Lecanto, Florida 34461
United States
Site 0173 - Mount Sinai Medical Center
Miami Beach, Florida 33140
United States
Site 0308 - Advent Health
Orlando, Florida 32803
United States
Site 0108 - Emory University Hospital
Atlanta, Georgia 30322
United States
Site 0236 - Memorial Health
Savannah, Georgia 31404
United States
Site 0324 - Illinois Cancer Specialists
Niles, Illinois 60714
United States
Site 0284 - Community Cancer Center North
Indianapolis, Indiana 46250
United States
Site 0217 - St Vincent Hospital and Health Care Centers
Indianapolis, Indiana 46260
United States
Site 0251 - Norton Cancer Institute
Louisville, Kentucky 40202
United States
Site 0146 - Maryland Oncology Hematology, PA
Rockville, Maryland 20876
United States
Site 0221 - Tufts Medical Center - PPDS
Boston, Massachusetts 02111
United States
Site 0104 - Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Site 0307 - Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United States
Site 0263 - Baystate Medical Center
Springfield, Massachusetts 01199
United States
Site 0101 - Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Site 0228 - Corewell Health Medical Group West
Grand Rapids, Michigan 49503
United States
Site 0288 - Minnesota Oncology Hematology - Maplewood
Maplewood, Minnesota 55109
United States
Site 0226 - CoxHealth
Springfield, Missouri 65807
United States
Site 0317 - Nebraska Methodist Hospital
Omaha, Nebraska 68114
United States
Site 0213 - Center of Hope
Reno, Nevada 89511
United States
Site 0231 - Northwell Health Cancer Institute
Manhasset, New York 11030
United States
Site 0126 - Wilmot Cancer Center
Rochester, New York 14642
United States
Site 0259 - Duke Cancer Center
Durham, North Carolina 27710
United States
Site 0147 - Trihealth Cancer Institute - Harold and Eugen
Cincinnati, Ohio 45242
United States
Site 0243 - Mark H Zangmeister Cancer Center
Columbus, Ohio 43219
United States
Site 0214-Ohio State University Comprehensive Cancer Center
Hilliard, Ohio 43026
United States
Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon
Eugene, Oregon 97401
United States
Site 0232 - University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Site 0178 - Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Site 0277 - Alliance Cancer Specialist, PC
Wynnewood, Pennsylvania 19096
United States
Site 0132 - Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
Site 0103 - University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Site 0234 - University of Texas Health, Memorial Hermann Hospital
Houston, Texas 77030
United States
Site 0203 - Texas Oncology
Tyler, Texas 75702
United States
Site 0295 - Virginia Oncology Associates
Chesapeake, Virginia 23320
United States
Site 0322 - Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Site 0323 - Compass Oncology
Vancouver, Washington 98684
United States
Site 2715 - Icon Cancer Centre - Chermside
Chermside, Queensland 4032
Australia
Site 2707 - Mater Brisbane
South Brisbane, Queensland 4101
Australia
Site 2709 - Cancer Research SA
Adelaide, South Australia 5037
Australia
Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens, South Australia 5065
Australia
Site 2716 - Epworth Healthcare Freemasons
East Melbourne, Victoria 3002
Australia
Site 2701 - Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
Australia
Site 2717 - St John of God Hospital Subiaco
Subiaco, Western Australia 6008
Australia
Site 3102 - Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital 1200
Belgium
Site 3101 - AZORG - Aalst
Aalst, Oost-Vlaanderen 9300
Belgium
Site 3105 - UZ Leuven
Leuven, Vlaams Brabant 3000
Belgium
Site 3616 - Centre Antoine Lacassagne
Nice, Alpes-Maritimes 06100
France
Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, Bas-Rhin 67200
France
Site 3601 - Centre Georges François Leclerc
Dijon, Côte-d'Or 21079
France
Site 3613 - CHRU Besancon - Hopital Jean Minjoz
Besançon, Doubs 25030
France
Site 3617 - CHU de Brest - Hôpital La Cavale Blanche
Brest, Finistere 29200
France
Site 3603 - Institut Claudius Regaud
Toulouse, Haute-Garonne 31000
France
Site 3602 - Centre Oscar Lambret
Lille, Nord 59000
France
Site 3615 - Hôpital Cochin Port-Royal AP-HP
Paris, Paris 75181
France
Site 3614 - Institut de Cancerologie de l'oust
Saint-Herblain, Pays de la Loire Region 44800
France
Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite, Rhône 69310
France
Site 3619 - Centre Léon Bérard
Lyon, 69373
France
Site 3620 - CHU de Strasbourg - Hopital de Hautepierre
Strasbourg, 67200
France
Site 3604 - Institut Gustave Roussy
Villejuif, 94800
France
Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, Campania 80131
Italy
Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Emilia-Romagna 41124
Italy
Site 3312 - Centro di Riferimento Oncologico
Aviano, Friuli Venezia Giulia 33081
Italy
Site 3304 - Fondazione Policlinico Universitario A Gemelli
Rome, Lazio 168
Italy
Site 3305 - Istituto Europeo di Oncologia
Milan, Lombardy 20141
Italy
Site 3307 - Ospedale San Raffaele S.r.l.
Milan, Milano 20132
Italy
Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto 37126
Italy
Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, 40138
Italy
Site 2414 - Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship 60-693
Poland
Site 2405 - Centrum Badan Klinicznych JCI
Krakow, Lesser Poland Voivodeship 30-348
Poland
Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship 02-781
Poland
Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
Bialystok, Podlaskie Voivodeship 15-027
Poland
Site 2421 - Szpitale Pomorskie Sp. z o. o.
Gdynia, Pomeranian Voivodeship 81-519
Poland
Site 2908 - National Cancer Center
Goyang-si, Gyeonggi-do 10408
South Korea
Site 2905 - Seoul National University Hospital
Seoul, 03080
South Korea
Site 2909 - Severance Hospital Yonsei University Health System
Seoul, 03722
South Korea
Site 2904 - Asan Medical Center
Seoul, 05505
South Korea
Site 2906 - Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
South Korea
Site 2907 - Samsung Medical Center
Seoul, 06351
South Korea
Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron
Barcelona, Barcelona 8035
Spain
Site 3517 - Clinica Universidad de Navarra
Madrid, Madrid 28027
Spain
Site 3516 - Hospital Universitario Virgen de La Arrixaca
Murcia, Murcia 30120
Spain
Site 3501 - Hospital Clinico Universitario de Valencia
Valencia, Valencia 46010
Spain
Site 3502 - Hospital Universitario La Paz
Madrid, 28046
Spain