A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)

Status: Recruiting
Location: See all (82) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Histological diagnosis of a 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 a 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.

• Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.

• Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.

• Must have received bevacizumab unless there was a contraindication for its use.

• If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.

Locations
United States
Alabama
Usa Health Mitchell Cancer Institute
NOT_YET_RECRUITING
Mobile
Arkansas
Uams Winthrop P Rockefeller Cancer Institute
NOT_YET_RECRUITING
Little Rock
California
University of California, Los Angeles Medical Center
NOT_YET_RECRUITING
Los Angeles
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
NOT_YET_RECRUITING
San Diego
Washington, D.c.
Medstar Georgetown University Hospital
NOT_YET_RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists & Research Institute
NOT_YET_RECRUITING
Fort Myers
Mayo Clinic
NOT_YET_RECRUITING
Jacksonville
Sylvester Comprehensive Cancer Center
NOT_YET_RECRUITING
Miami
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Florida Cancer Specialists & Research Institute
NOT_YET_RECRUITING
West Palm Beach
Georgia
Northeast Georgia Medical Center Gainesville
NOT_YET_RECRUITING
Gainesville
Iowa
University of Iowa Hospital and Clinics
NOT_YET_RECRUITING
Iowa City
Indiana
Parkview Research Center
NOT_YET_RECRUITING
Fort Wayne
Kentucky
Norton Cancer Institute
NOT_YET_RECRUITING
Louisville
Louisiana
Trials365, Llc
RECRUITING
Shreveport
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Umass Memorial Medical Center, Inc.
NOT_YET_RECRUITING
Worcester
Maryland
Greater Baltimore Medical Center
RECRUITING
Baltimore
John Hopkins University-School of Medicine
WITHDRAWN
Baltimore
Michigan
University of Michigan Health System
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Minnesota Oncology-Minneapolis
NOT_YET_RECRUITING
Minneapolis
Missouri
Washington University
NOT_YET_RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
Montana
St. Vincent Regional Hospital - West End Clinic
NOT_YET_RECRUITING
Billings
Nebraska
Methodist Hospital Methodist Estabrook Cancer Center
RECRUITING
Omaha
New Jersey
John Theurer Cancer Center, Hackensack University Medical Center
NOT_YET_RECRUITING
Hackensack
New York
Laura and Isaac Perlmutter Cancer Center
RECRUITING
New York
University of Rochester, James P. Wilmot Cancer Center
NOT_YET_RECRUITING
Rochester
State University of New York Upstate Medical Unive
NOT_YET_RECRUITING
Syracuse
Ohio
Oncology Hematology Care, Inc
NOT_YET_RECRUITING
Cincinnati
The Mark H Zangmeister Cancer Center Ohio
RECRUITING
Columbus
Pennsylvania
Penn State College of Medicine
NOT_YET_RECRUITING
Hershey
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Texas
Texas Oncology-Austin Center
NOT_YET_RECRUITING
Austin
Houston Methodist Cancer Center
NOT_YET_RECRUITING
Houston
Cancer Care Center of South Texas-Medical Center
NOT_YET_RECRUITING
San Antonio
Texas Oncology-Tyler
NOT_YET_RECRUITING
Tyler
Utah
Utah Cancer Specialists
NOT_YET_RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists, Pc
NOT_YET_RECRUITING
Fairfax
Carilion Clinic
NOT_YET_RECRUITING
Roanoke
Wisconsin
Froedtert & the Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
West Virginia
West Virginia University
NOT_YET_RECRUITING
Morgantown
Other Locations
Australia
Burnside War Memorial Hospital - the Brian Fricker Oncology Centre
NOT_YET_RECRUITING
Adelaide
Cancer Research Sa (Crsa)
NOT_YET_RECRUITING
Adelaide
Blacktown Cancer & Haematology Centre-Blacktown Hospital
NOT_YET_RECRUITING
Blacktown
Concord General Repatriation Hospital
NOT_YET_RECRUITING
Concord
Hobart Hospital-Royal Hobart Hospital
NOT_YET_RECRUITING
Hobart
Southern Oncology Clinical Research Unit
NOT_YET_RECRUITING
South Australia
Belgium
Cliniques Universitaires St Luc Ucl
NOT_YET_RECRUITING
Brussels
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
NOT_YET_RECRUITING
Brussels
Az Groeninge Campus Kennedylaan
NOT_YET_RECRUITING
Kortrijk
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING
Leuven
Chu Liege
NOT_YET_RECRUITING
Liège
Japan
Hyogo Cancer Center
RECRUITING
Akashi-shi
Saitama Medical University International Medical Center
RECRUITING
Hidaka-shi
The Cancer Institute Hospital of Jfcr
RECRUITING
Kōtoku
Kurume University Hospital
RECRUITING
Kurume
Nho Shikoku Cancer Center
RECRUITING
Matsuyama
Hokkaido University Hospital
RECRUITING
Sapporo
Shizuoka Cancer Center
NOT_YET_RECRUITING
Sunto-gun
Puerto Rico
Panoncology Trials
RECRUITING
San Juan
Spain
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall D'Hebron
NOT_YET_RECRUITING
Barcelona
Instituto Catalan de Oncologia - Hospital Duran I Reynals
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Institut Catala D'Oncologia Girona
NOT_YET_RECRUITING
Girona
Clinica Universidad de Navarra - Sede Madrid
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de La Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
NOT_YET_RECRUITING
Valencia
Instituto Valenciano de Oncologia
NOT_YET_RECRUITING
Valencia
Switzerland
Istituto Oncologico Della Svizzera Italiana
NOT_YET_RECRUITING
Bellinzona
Kantonsspital Graubunden
NOT_YET_RECRUITING
Chur
Geneva University Hospitals-Hug
NOT_YET_RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
NOT_YET_RECRUITING
Lausanne
Kantonsspital Baselland (Ksbl) - Standort Liestal - Medizinische Universitatsklinik
WITHDRAWN
Liestal
United Kingdom
Western General Hospital - Lothian Health Board
NOT_YET_RECRUITING
Edinburgh
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
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
NOT_YET_RECRUITING
London
St Bartholomew'S Hospital
NOT_YET_RECRUITING
London
The Christie Nhs Foundation Trust
NOT_YET_RECRUITING
Manchester
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: 2025-11-12
Estimated Completion Date: 2027-10-24
Participants
Target number of participants: 160
Treatments
Experimental: Cohort 1
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Experimental: Cohort 2
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Experimental: Cohort 3
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in 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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