Ovarian Cancer Clinical Trials

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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

Status: Recruiting
Location: See all (155) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
City of Hope Medical Center
NOT_YET_RECRUITING
Duarte
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Georgia
Georgia Cancer Center
NOT_YET_RECRUITING
Augusta
Illinois
Northshore University Health System-Evanston Hospital
NOT_YET_RECRUITING
Evanston
Carle Cancer Center
NOT_YET_RECRUITING
Urbana
Louisiana
Women'S Cancer Care
NOT_YET_RECRUITING
Covington
Maryland
Holy Cross Hospital
NOT_YET_RECRUITING
Silver Spring
Maine
Maine Center For Cancer Medicine
NOT_YET_RECRUITING
Scarborough
Missouri
Mercy Hospital St. Louis - David C. Pratt Cancer Center
NOT_YET_RECRUITING
St Louis
Montana
Billings Clinic
RECRUITING
Billings
North Carolina
Levine Cancer Center
NOT_YET_RECRUITING
Charlotte
Novant Presbyterian Hospital
NOT_YET_RECRUITING
Charlotte
Atrium Health Wake Forest Baptist
NOT_YET_RECRUITING
Winston-salem
Novant Health Forysth Medical Center
NOT_YET_RECRUITING
Winston-salem
Oregon
Oncology Associates of Oregon, P.C.
NOT_YET_RECRUITING
Eugene
Providence Cancer Institute Franz Clinic
NOT_YET_RECRUITING
Portland
Pennsylvania
University of Pittsburgh Cancer Institute Cancer Services
NOT_YET_RECRUITING
Pittsburgh
Wellspan Gynecologic Oncology
NOT_YET_RECRUITING
York
South Dakota
Sanford Gynecologic Oncology Clinic
NOT_YET_RECRUITING
Sioux Falls
Tennessee
Erlanger Health, Inc.
NOT_YET_RECRUITING
Chattanooga
Texas
Texas Oncology-Abilene
NOT_YET_RECRUITING
Abilene
Virginia
Inova Schar Cancer Institute
NOT_YET_RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center
WITHDRAWN
Madison
Other Locations
Australia
Eastern Health-Box Hill Hospital
NOT_YET_RECRUITING
Box Hill
Chris O'Brien Lifehouse Hospital
NOT_YET_RECRUITING
Camperdown
North Coast Cancer Institute
WITHDRAWN
Port Macquarie
Icon Cancer Care - Townsville
NOT_YET_RECRUITING
Townsville
The Wollongong Hospital
NOT_YET_RECRUITING
Wollongong
Belgium
Cliniques Universitaires St Luc Ucl
NOT_YET_RECRUITING
Brussels
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
NOT_YET_RECRUITING
Brussels
Az Maria Middelares Gent
NOT_YET_RECRUITING
Ghent
UZ GENT
NOT_YET_RECRUITING
Ghent
Az Groeninge
NOT_YET_RECRUITING
Kortrijk
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING
Leuven
Canada
British Columbia Cancer Agency (Bcca) - Abbotsford Regional Hospital and Cancer Centre (Arhcc)
WITHDRAWN
Abbotsford British Columbia
Arthur J E Child Comprehensive Cancer Centre
NOT_YET_RECRUITING
Calgary
Cross Cancer Institute
NOT_YET_RECRUITING
Edmonton
London Health Sciences Centre
NOT_YET_RECRUITING
London
Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site
NOT_YET_RECRUITING
Montreal
Sir Mortimer B. Davis - Jewish General Hospital
NOT_YET_RECRUITING
Montreal
Sunnybrook Health Science Centre
WITHDRAWN
Toronto
University Health Network (Uhn) - Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
Bc Cancer Vancouver
WITHDRAWN
Vancouver
France
Ch Davignon - Hopital Henri Duffaut
NOT_YET_RECRUITING
Avignon
Clinique Tivoli
NOT_YET_RECRUITING
Bordeaux
Clinique Pole Sante Leonard de Vinci
NOT_YET_RECRUITING
Chambray-lès-tours
Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies
NOT_YET_RECRUITING
La Roche-sur-yon
Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon
NOT_YET_RECRUITING
La Tronche
Hopital Prive Jean Mermoz
NOT_YET_RECRUITING
Lyon
Institut Paoli Calmettes
NOT_YET_RECRUITING
Marseille
Centre Antoine Laccassagne
NOT_YET_RECRUITING
Nice
Tenon - Aphp
NOT_YET_RECRUITING
Paris
Centre Eugene Marquis
NOT_YET_RECRUITING
Rennes
Hopital de Hautepierre
NOT_YET_RECRUITING
Strasbourg
Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep
NOT_YET_RECRUITING
Villejuif
Germany
Universitätsklinikum Bonn
NOT_YET_RECRUITING
Bonn
University Clinic Carl Gustav Carus Technical University Dresden
NOT_YET_RECRUITING
Dresden
Vidia Christliche Kliniken Karlsruhe
WITHDRAWN
Karlsruhe
Klinikum Kassel
NOT_YET_RECRUITING
Kassel
Universitatsklinikum Schleswig Holstein
NOT_YET_RECRUITING
Kiel
Universitätsmedizin Mannheim
NOT_YET_RECRUITING
Mannheim
Johannes Wesling Klinikum Minden
NOT_YET_RECRUITING
Minden
Lmu - Klinikum Der Universitaet Muenchen - Campus Grosshadern
NOT_YET_RECRUITING
München
Universitaetsklinikum Tuebingen (Ukt)
NOT_YET_RECRUITING
Tübingen
Universitätsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Ireland
St. James Hospital
NOT_YET_RECRUITING
Dublin
St. Vincent'S University Hospital
NOT_YET_RECRUITING
Dublin
University Hospital Waterford
NOT_YET_RECRUITING
Waterford
Italy
Ss Antonio & Biagio and C. Arrigo Hospital
NOT_YET_RECRUITING
Alessandria
Centro Di Riferimento Oncologico (Cro Aviano)
NOT_YET_RECRUITING
Aviano
Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna
NOT_YET_RECRUITING
Bologna
Ospedale Careggi
NOT_YET_RECRUITING
Florence
Ospedale Manzoni
NOT_YET_RECRUITING
Lecco
Fondazione Irccs Istituto Nazionale Dei Tumori
NOT_YET_RECRUITING
Milan
Humanitas San Pio X
NOT_YET_RECRUITING
Milan
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto
NOT_YET_RECRUITING
Milan
Azienda Ulss 3 Serenissima - Ospedale Di Mirano
NOT_YET_RECRUITING
Mirano
Istituto Nazionale Tumori Irccs Fondazione Pascale
NOT_YET_RECRUITING
Naples
Comitato Etico Irccs Istituto Oncologico Veneto Di Padova
NOT_YET_RECRUITING
Padova
Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Ausl Di Placenza Ospedale Guglielmo Da Saliceto
NOT_YET_RECRUITING
Placenza
Ospedale Santa Maria Delle Croci
NOT_YET_RECRUITING
Ravenna
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Universita Cattolica Del Sacro Cuore
NOT_YET_RECRUITING
Rome
Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena (Ire)
NOT_YET_RECRUITING
Rome
Ordine Mauriziano - Ospedale Umberto I Di Torino
NOT_YET_RECRUITING
Torino
Ospedale Ca' Foncello
NOT_YET_RECRUITING
Treviso
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
NOT_YET_RECRUITING
Udine
Ospedale Ferrero
NOT_YET_RECRUITING
Verduno
Japan
Hyogo Cancer Center
NOT_YET_RECRUITING
Akashi-shi
Saitama Medical University International Medical Center
NOT_YET_RECRUITING
Hidaka-shi
The Cancer Institute Hospital of Jfcr
NOT_YET_RECRUITING
Kōtoku
Kurume University Hospital
NOT_YET_RECRUITING
Kurume
Nho Shikoku Cancer Center
NOT_YET_RECRUITING
Matsuyama
The Jikei University Hospital
RECRUITING
Minatoku
Aichi Cancer Center
NOT_YET_RECRUITING
Nagoya
Okayama University Hospital
NOT_YET_RECRUITING
Okayama
Osaka International Cancer Institute
NOT_YET_RECRUITING
Osaka
Hokkaido University Hospital
NOT_YET_RECRUITING
Sapporo
Sapporo Medical University Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Iwate Medical University Hospital
NOT_YET_RECRUITING
Shiwa-gun
Shizuoka Cancer Center
NOT_YET_RECRUITING
Sunto-gun
National Cancer Center Hospital
NOT_YET_RECRUITING
Tokyo
Netherlands
Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)
NOT_YET_RECRUITING
Amsterdam
University Medical Center Groningen
NOT_YET_RECRUITING
Groningen
Radboud University Medical Center
NOT_YET_RECRUITING
Nijmegen
Erasmus Medisch Centrum 1
NOT_YET_RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht (Umc Utrecht)
NOT_YET_RECRUITING
Utrecht
Poland
Uniwersyteckie Centrum Onkologii
NOT_YET_RECRUITING
Bialystok
Gdanski Uniwersytet Medyczny
NOT_YET_RECRUITING
Gdansk
Swietokrzyskie Centrum Onkologii Spzoz
NOT_YET_RECRUITING
Kielce
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
NOT_YET_RECRUITING
Siedlce
Republic of Korea
Cha University Bundang Cha Medical Center
NOT_YET_RECRUITING
Gyeonggi-do
National Cancer Center
NOT_YET_RECRUITING
Gyeonggi-do
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Gyeonggi-do
Ewha Womans University Mokdong Hospital
NOT_YET_RECRUITING
Seoul
Konkuk University Medical Center
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Seoul St. Mary'S Hospital
NOT_YET_RECRUITING
Seoul
Asan Medical Center
NOT_YET_RECRUITING
Songpa-gu, Seoul
Spain
Hospital Universitario de Alava
NOT_YET_RECRUITING
Alava
Ico-Badalona
NOT_YET_RECRUITING
Badalona
Hospital Clinic de Barcelona
NOT_YET_RECRUITING
Barcelona
Clinica Universidad de Navarra
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de La Victoria
NOT_YET_RECRUITING
Málaga
Hospital Universitario Central de Asturias
NOT_YET_RECRUITING
Oviedo, Asturias
Hospital Son Espases. Mallorca
NOT_YET_RECRUITING
Palma De Mallorca
Corporacio Sanitaria Universitaria Parc Tauli
NOT_YET_RECRUITING
Sabadell
Hospital Universitario Virgen de Valme
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen Del Rocío Sevilla
NOT_YET_RECRUITING
Seville
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
NOT_YET_RECRUITING
Valencia
Switzerland
Ospedale Regionale Di Bellinzona
NOT_YET_RECRUITING
Bellinzona
Kantonsspital Graubunden
NOT_YET_RECRUITING
Chur
Kantonsspital Frauenfeld
NOT_YET_RECRUITING
Frauenfeld
Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)
NOT_YET_RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
NOT_YET_RECRUITING
Lausanne
University Hospital of Zurich
NOT_YET_RECRUITING
Zurich
United Kingdom
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
Cambridge
Velindre Nhs Trust, Velindre Cancer Centre
NOT_YET_RECRUITING
Cardiff
Edinburgh Cancer Centre Western General Hospital
WITHDRAWN
Edinburgh
Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust
NOT_YET_RECRUITING
Guildford
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
NOT_YET_RECRUITING
Leeds
Clatterbridge Cancer Center
NOT_YET_RECRUITING
Liverpool
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
NOT_YET_RECRUITING
London
Hammersmith Hospital - Imperial College Healthcare Nhs Trust
NOT_YET_RECRUITING
London
University College London Hospitals - University College London Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
London
The Christie Nhs Foundation Trust
NOT_YET_RECRUITING
Manchester Greater
Northampton General Hospital - Northampton General Hospital Nhs Trust
NOT_YET_RECRUITING
Northampton
Mount Vernon
NOT_YET_RECRUITING
Northwood
Royal Marsden Hospital
NOT_YET_RECRUITING
Sutton
Musgrove Park Hospital - Somerset Nhs Foundation Trust
NOT_YET_RECRUITING
Taunton
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2029-05-14
Participants
Target number of participants: 466
Treatments
Experimental: Treatment Group A (TGA)
INCB123667 at the protocol-defined dose.
Experimental: Treatment Group B (TGB)
Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.
Related Therapeutic Areas
Sponsors
Collaborators: ENGOT Foundation, GOG Foundation
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov

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