What this study is
The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.
What's being tested
- INCB123667
Intervention · DRUG
Oral; tablet
- Investigator's choice of chemotherapy
Intervention · DRUG
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Study details
- Official title
- A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
- Sponsor
- Incyte Corporation
- Conditions
- Ovarian Cancer
- Enrolling
- 466 people
- Starts
- 2025-12-09
- Est. completion
- 2029-05-14
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Have platinum-resistant disease.; Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.; Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
- Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
- Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
- Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
- Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
- Measurable disease per RECIST v1.1.
You can't join if
- Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
- Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
- Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
- Clinically significant gastrointestinal abnormalities.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (198)
87 openCity of Hope Medical Center
Duarte, California, United States
RecruitingValkyrie Clinical Trials
Los Angeles, California, United States
RecruitingMount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, United States
Not yet recruitingWomen'S Cancer Care
Covington, Louisiana, United States
Not yet recruitingTrials365, Llc
Shreveport, Louisiana, United States
Not yet recruitingGreater Baltimore Medical Center
Towson, Maryland, United States
Not yet recruitingBillings Clinic
Billings, Montana, United States
RecruitingMaimonides Medical Center
Short Hills, New Jersey, United States
Not yet recruitingLevine Cancer Center
Charlotte, North Carolina, United States
Not yet recruitingNovant Presbyterian Hospital
Charlotte, North Carolina, United States
RecruitingNovant Health Oncology Specialists
Winston-Salem, North Carolina, United States
RecruitingAtrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Not yet recruitingOncology Associates of Oregon, P.C.
Eugene, Oregon, United States
RecruitingProvidence Cancer Institute Franz Clinic
Portland, Oregon, United States
RecruitingPenn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Not yet recruitingUniversity of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, United States
RecruitingSanford Cancer Center-Sioux Falls
Sioux Falls, South Dakota, United States
RecruitingErlanger Health, Inc.
Chattanooga, Tennessee, United States
RecruitingTexas Oncology-Abilene
Abilene, Texas, United States
RecruitingTexas Oncology Cancer Center
Austin, Texas, United States
Not yet recruitingTexas Oncology, P.A., San Antonio Medical Center - Uso
San Antonio, Texas, United States
Not yet recruitingTexas Oncology Cancer Center
Sugar Land, Texas, United States
RecruitingTexas Oncology (Txo) Northeast Texas (Tyler)
Tyler, Texas, United States
Not yet recruitingProvidence Sacred Heart Medical Center and Children'S Hospital
Spokane, Washington, United States
Not yet recruitingAlaska Womens Cancer Care Akwcc
Anchorage, Alaska, United States
CompletedUniversity of Arizona Cancer Center
Tucson, Arizona, United States
CompletedProvidence Medical Foundation
Fullerton, California, United States
CompletedUniversity of California, San Diego-Moores Cancer Center
La Jolla, California, United States
CompletedUci Health Chao Family Comprehensive Cancer Center
Orange, California, United States
CompletedVentura County Hematology Oncology Specialists-Oxnard
Oxnard, California, United States
CompletedUniversity of Colorado Cancer Center
Aurora, Colorado, United States
CompletedBrcr Global
Miramar, Florida, United States
CompletedSarasota Memorial Health Care System
Sarasota, Florida, United States
CompletedWinship Cancer Institute At Emory University
Atlanta, Georgia, United States
CompletedGeorgia Cancer Center
Augusta, Georgia, United States
CompletedThe University of Chicago Medicine
Chicago, Illinois, United States
CompletedCarle Cancer Center
Effingham, Illinois, United States
CompletedNorthshore University Health System-Evanston Hospital
Evanston, Illinois, United States
CompletedCity of Hope - Chicago Cancer Center
Zion, Illinois, United States
CompletedSt Elizabeth Healthcare
Edgewood, Kentucky, United States
CompletedMaine Center For Cancer Medicine
Scarborough, Maine, United States
CompletedHoly Cross Hospital
Silver Spring, Maryland, United States
CompletedHenry Ford Cancer - Detroit
Detroit, Michigan, United States
CompletedMercy Hospital St. Louis - David C. Pratt Cancer Center
St Louis, Missouri, United States
CompletedWomen'S Cancer Center of Nevada
Las Vegas, Nevada, United States
CompletedCenter of Hope
Reno, Nevada, United States
CompletedUnm Comprehensive Cancer Center
Albuquerque, New Mexico, United States
CompletedEast Carolina University
Greenville, North Carolina, United States
CompletedCleveland Clinic Foundation
Cleveland, Ohio, United States
CompletedOhio Health Research Institute
Columbus, Ohio, United States
CompletedMiami Valley Hospital South
Dayton, Ohio, United States
CompletedPromedica Flower Hospital
Sylvania, Ohio, United States
CompletedAllegheny Health Network- West Penn Hospital
Pittsburgh, Pennsylvania, United States
CompletedLankenau Medical Center
Wynnewood, Pennsylvania, United States
CompletedWellspan Gynecologic Oncology
York, Pennsylvania, United States
CompletedJps Health Network
Fort Worth, Texas, United States
CompletedThe University of Texas Health Science Center Houston
Houston, Texas, United States
CompletedThe University of Texas-Md Anderson Cancer Center
Houston, Texas, United States
CompletedUniversity of Virginia Health System
Charlottesville, Virginia, United States
CompletedInova Schar Cancer Institute
Fairfax, Virginia, United States
CompletedFred Hutchinson Cancer Center
Seattle, Washington, United States
CompletedWest Virginia University
Morgantown, West Virginia, United States
CompletedProhealth Care
Waukesha, Wisconsin, United States
Completed
135 sites outside the US
Icon Cancer Care - Townsville
Townsville, Queensland, Australia
RecruitingEastern Health-Box Hill Hospital
Box Hill, Victoria, Australia
RecruitingAz Maria Middelares Gent
Ghent, Belgium
RecruitingAz Groeninge
Kortrijk, Belgium
Not yet recruitingUniversitair Ziekenhuis Leuven
Leuven, Belgium
Not yet recruitingTom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary
Calgary, Alberta, Canada
Not yet recruitingCedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site
Montreal, Quebec, Canada
RecruitingClinique Pole Sante Leonard de Vinci
Chambray-lès-Tours, France
Not yet recruitingHopital Prive Jean Mermoz
Lyon, France
RecruitingHospital Tenon
Paris, France
Not yet recruitingCharite Campus Virchow
Berlin, Germany
Not yet recruitingUniversitaetsklinikum Bonn
Bonn, Germany
Not yet recruitingUniversitaetsklinikum Dresden
Dresden, Germany
Not yet recruitingKliniken Essen-Mitte
Essen, Germany
Not yet recruitingKlinikum Kassel Gmbh
Kassel, Germany
Not yet recruitingUniversitatsklinikum Schleswig Holstein
Kiel, Germany
Not yet recruitingUniversitätsmedizin Mannheim
Mannheim, Germany
Not yet recruitingJohannes Wesling Klinikum Minden
Minden, Germany
Not yet recruitingUniversitaetsklinikum Tuebingen (Ukt)
Tübingen, Germany
Not yet recruitingHyogo Cancer Center
Akashi-shi, Japan
RecruitingSaitama Medical University International Medical Center
Hidaka-shi, Japan
RecruitingThe Cancer Institute Hospital of Jfcr
Kōtoku, Japan
RecruitingKurume University Hospital
Kurume, Japan
RecruitingShikoku Cancer Center
Matsuyama, Japan
RecruitingThe Jikei University Hospital
Minatoku, Japan
RecruitingAichi Cancer Center
Nagoya, Japan
RecruitingOkayama University Hospital
Okayama, Japan
RecruitingOsaka International Cancer Institute
Osaka, Japan
RecruitingSapporo Medical University Hospital
Sapporo, Japan
RecruitingHokkaido University Hospital
Sapporo, Japan
RecruitingTohoku University Hospital
Sendai, Japan
RecruitingIwate Medical University Hospital
Shiwa-gun, Japan
RecruitingShizuoka Cancer Center
Shizuoka, Japan
RecruitingNational Cancer Center Hospital
Tokyo, Japan
Not yet recruitingUniversity Medical Center Groningen
Groningen, Netherlands
RecruitingRadboud University Medical Center
Nijmegen, Netherlands
RecruitingUniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, Poland
Not yet recruitingGdanski Uniwersytet Medyczny
Gdansk, Poland
Not yet recruitingSwietokrzyskie Centrum Onkologii Spzoz
Kielce, Poland
Not yet recruitingMazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce, Poland
Not yet recruitingUniwersytecki Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego W Szczecinie
Szczecin, Poland
Not yet recruitingCha Ilsan Medical Center
Goyang-si, South Korea
Not yet recruitingSamsung Medical Center
Seoul, South Korea
RecruitingSeoul St. Mary'S Hospital
Seoul, South Korea
Not yet recruitingHospital Clinic de Barcelona
Barcelona, Spain
Not yet recruitingHospital Universitario La Paz
Madrid, Spain
RecruitingHospital Universitario Virgen de La Victoria
Málaga, Spain
RecruitingOspedale Regionale Di Bellinzona
Bellinzona, Switzerland
RecruitingKantonsspital Frauenfeld
Frauenfeld, Switzerland
RecruitingHopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)
Geneva, Switzerland
RecruitingCentre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
Lausanne, Switzerland
RecruitingAddenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
RecruitingRoyal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust
Guildford, United Kingdom
RecruitingSt James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
RecruitingClatterbridge Cancer Center
Liverpool, United Kingdom
RecruitingUniversity College London Hospitals - University College London Hospitals Nhs Foundation Trust
London, United Kingdom
RecruitingGuy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, United Kingdom
RecruitingRoyal Marsden Hospital - London
London, United Kingdom
RecruitingThe Christie Nhs Foundation Trust
Manchester Greater, United Kingdom
RecruitingNorthampton General Hospital - Northampton General Hospital Nhs Trust
Northampton, United Kingdom
RecruitingMount Vernon Cancer Centre
Northwood, United Kingdom
Not yet recruitingRoyal Marsden Hospital - Sutton
Sutton, United Kingdom
RecruitingMusgrove Park Hospital - Somerset Nhs Foundation Trust
Taunton, United Kingdom
RecruitingChris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia
CompletedConcord Repatriation General Hospital
Concors, New South Wales, Australia
CompletedThe Wollongong Hospital
Wollongong, New South Wales, Australia
CompletedMater Hospital Brisbane
South Brisbane, Queensland, Australia
CompletedHopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels, Belgium
CompletedCliniques Universitaires St Luc Ucl
Brussels, Belgium
CompletedUZ GENT
Ghent, Belgium
CompletedCross Cancer Insititute
Edmonton, Alberta, Canada
CompletedLondon Health Sciences Centre
London, Ontario, Canada
CompletedUniversity Health Network (Uhn) - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CompletedSir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada
CompletedCh Davignon - Hopital Henri Duffaut
Avignon, France
CompletedClinique Tivoli
Bordeaux, France
CompletedCentre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies
La Roche-sur-Yon, France
CompletedCentre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon
La Tronche, France
CompletedInstitut Paoli Calmettes
Marseille, France
CompletedCentre Antoine Laccassagne
Nice, France
CompletedCentre Eugene Marquis
Rennes, France
CompletedHopital de Hautepierre
Strasbourg, France
CompletedInstitut Gustave Roussy-Gustave Roussy Cancer Center -Ditep
Villejuif, France
CompletedSt. Vincent'S University Hospital
Dublin, Ireland
CompletedMater Misericordiae University Hospital
Dublin, Ireland
CompletedSt. James Hospital
Dublin, Ireland
CompletedUniversity College Hospital Galway
Galway, Ireland
CompletedUniversity Hospital Waterford
Waterford, Ireland
CompletedAzienda Sanitaria Locale (Asl) Cn2 Alba-Bra
Alba, Italy
CompletedSs Antonio & Biagio and C. Arrigo Hospital
Alessandria, Italy
CompletedCentro Di Riferimento Oncologico Di Aviano
Aviano, Italy
CompletedAou Policlinico S. Orsola-Malpighi
Bologna, Italy
CompletedOspedale Careggi
Florence, Italy
CompletedAzienda Socio Santaria Territoriale de Lecco - Ospedale A. Manzoni
Lecco, Italy
CompletedOspedale San Raffaele Irccs
Milan, Italy
CompletedHumanitas San Pio X
Milan, Italy
CompletedAzienda Ulss 3 Serenissima - Ospedale Di Mirano
Mirano, Italy
CompletedIstituto Nazionale Tumori Irccs Fondazione Pascale
Naples, Italy
CompletedIov - Istituto Oncologico Veneto Irccs
Padova, Italy
CompletedIrccs Fondazione Policlinico San Matteo
Pavia, Italy
CompletedAusl Di Placenza Ospedale Guglielmo Da Saliceto
Piacenza, Italy
CompletedOspedale Santa Maria Delle Croci
Ravenna, Italy
CompletedIrccs Istituto Nazionale Tumori Regina Elena (Irccs Regina Elena National Cancer Institute)
Roma, Italy
CompletedPoliclinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, Italy
CompletedAzienda Ospedaliera Ordine Mauriziano Di Torino
Torino, Italy
CompletedOspedale Ca' Foncello
Treviso, Italy
CompletedAzienda Ospedaliero-Universitaria Friuli Centrale
Udine, Italy
CompletedNki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)
Amsterdam, Netherlands
CompletedUniversitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, Netherlands
CompletedBrcr Global - Yauco
Yauco, PR, Puerto Rico
CompletedBrcr Global - Hato Rey
San Juan, Puerto Rico
CompletedKorea University Ansan Hospital
Ansan-si, South Korea
CompletedSamsung Changwon Hospital
Changwon-si, South Korea
CompletedKeimyung University Dongsan Hospital
Daegu, South Korea
CompletedNational Cancer Center
Goyang-si, South Korea
CompletedCha University Bundang Cha Medical Center
Seongnam-si, South Korea
CompletedSeoul National University Bundang Hospital (Snubh)
Seongnam-si, South Korea
CompletedKorea University Anam Hospital
Seoul, South Korea
CompletedSeoul National University Hospital
Seoul, South Korea
CompletedSeverance Hospital Yonsei University Health System
Seoul, South Korea
CompletedKonkuk University Medical Center
Seoul, South Korea
CompletedAsan Medical Center
Seoul, South Korea
CompletedEwha Womans University Mokdong Hospital
Seoul, South Korea
CompletedHospital Universitario de Alava
Alava, Spain
CompletedIco-Badalona
Badalona, Spain
CompletedClinica Universidad de Navarra
Madrid, Spain
CompletedHospital Universitario Central de Asturias
Oviedo, Spain
CompletedHospital Universitari Son Espases
Palma, Spain
CompletedCorporacio Sanitaria Universitaria Parc Tauli
Sabadell, Spain
CompletedHospital Universitario Virgen Del Rocio
Seville, Spain
CompletedHospital Universitario Virgen de Valme
Seville, Spain
CompletedFundacion Instituto Valenciano de Oncologia
Valencia, Spain
CompletedKantonsspital Graubunden
Chur, Switzerland
CompletedUniversity Hospital of Zurich
Zurich, Switzerland
CompletedVelindre Nhs Trust, Velindre Cancer Centre
Cardiff, United Kingdom
Completed
Study team
Sponsor
Incyte Corporation
Study ID INCB123667-305
Study director
Incyte Medical Monitor
Incyte Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.