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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-3129 | Other Identifier | GOG Study Number | |
| 2025-521513-14-00 | Registry Identifier | EU CT Number | |
| OV94 | Other Identifier | ENGOT Study Number |
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| Name | Class |
|---|---|
| ENGOT Foundation | UNKNOWN |
| GOG Foundation | NETWORK |
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This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
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| Cohort 2 | Experimental | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
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| Cohort 3 | Experimental | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB123667 | Drug | Administered orally twice daily (BID). |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response by IRC | Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) by IRC | Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first. | Up to 2 years |
| Progression-Free Survival (PFS) by IRC |
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Inclusion Criteria:
Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Have platinum-resistant disease:
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.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usa Health Mitchell Cancer Institute | Recruiting | Mobile | Alabama | 36604 | United States | |
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| Label | URL |
|---|---|
| A study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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Defined as the time from the date of first dose of study drug until the earliest date of disease progression as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first. |
| Up to 2 years |
| Overall Survival (OS) | Defined as the time from the date of first dose of study drug until death due to any cause. | Up to 2 years |
| Objective Response by Investigator | Defined as having a confirmed best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1. | Up to 2 years |
| DOR by investigator | Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first. | Up to 2 years |
| PFS by Investigator | Defined as the time from the date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first. | Up to 2 years |
| Treatment Emergent Adverse Events (TEAE'S) | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first. | Up to 2 years and 30 days |
| TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment | TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment. | Up to 2 years and 30 days |
| University of California, Los Angeles Medical Center |
| Recruiting |
| Los Angeles |
| California |
| 90024-6995 |
| United States |
| Scripps Healthscripps Mercy Hospital Prebys Cancer Center | Recruiting | San Diego | California | 92103 | United States |
| Medstar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Cancer Specialists & Research Institute | Recruiting | Fort Myers | Florida | 33901 | United States |
| Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
| Mount Sinai Comprehensive Cancer Center | Recruiting | Miami Beach | Florida | 33140 | United States |
| Florida Cancer Specialists & Research Institute | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Northeast Georgia Medical Center Gainesville | Recruiting | Gainesville | Georgia | 30501 | United States |
| Parkview Research Center | Recruiting | Fort Wayne | Indiana | 46845 | United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Withdrawn | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospital and Clinics | Recruiting | Iowa City | Iowa | 52242-1009 | United States |
| Norton Cancer Institute | Recruiting | Louisville | Kentucky | 40207 | United States |
| Trials365, Llc | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Greater Baltimore Medical Center | Recruiting | Baltimore | Maryland | 21204 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Umass Memorial Medical Center, Inc. | Not yet recruiting | Worcester | Massachusetts | 01605 | United States |
| University of Michigan Health System | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Oncology-Minneapolis | Recruiting | Minneapolis | Minnesota | 55404 | United States |
| University of Mississippi Medical Center | Not yet recruiting | Jackson | Mississippi | 39216 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| St. Vincent Regional Hospital - West End Clinic | Recruiting | Billings | Montana | 59106 | United States |
| Nebraska Methodist Hospital | Recruiting | Omaha | Nebraska | 68114 | United States |
| John Theurer Cancer Center, Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Laura and Isaac Perlmutter Cancer Center | Recruiting | New York | New York | 10016 | United States |
| University of Rochester, James P. Wilmot Cancer Center | Withdrawn | Rochester | New York | 14642 | United States |
| State University of New York Upstate Medical Unive | Recruiting | Syracuse | New York | 13210 | United States |
| Oncology Hematology Care, Inc | Recruiting | Cincinnati | Ohio | 45242 | United States |
| The Mark H Zangmeister Cancer Center Ohio | Recruiting | Columbus | Ohio | 43219 | United States |
| The Ohio State University Wexner Medical Center Division of Gynecologic Oncology | Recruiting | Hilliard | Ohio | 43026 | United States |
| Penn State College of Medicine | Recruiting | Hershey | Pennsylvania | 17033 | United States |
| Asplundh Cancer Pavilion - Thomas Jefferson | Withdrawn | Willow Grove | Pennsylvania | 19090 | United States |
| Medical University of South Carolina | Not yet recruiting | Charleston | South Carolina | 29425 | United States |
| Texas Oncology-Austin Center | Recruiting | Austin | Texas | 78731 | United States |
| Houston Methodist Cancer Center | Withdrawn | Houston | Texas | 77030 | United States |
| Texas Oncology-San Antonio Medical Center Pharmacy | Recruiting | San Antonio | Texas | 78229 | United States |
| Texas Oncology-Tyler | Recruiting | Tyler | Texas | 75702 | United States |
| Utah Cancer Specialists | Recruiting | Salt Lake City | Utah | 84106 | United States |
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
| Carilion Clinic | Recruiting | Roanoke | Virginia | 24016-4962 | United States |
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
| Froedtert & the Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Blacktown Cancer & Haematology Centre-Blacktown Hospital | Not yet recruiting | Blacktown | New South Wales | 02148 | Australia |
| Concord General Repatriation Hospital | Not yet recruiting | Concord | New South Wales | 02139 | Australia |
| Burnside War Memorial Hospital - the Brian Fricker Oncology Centre | Recruiting | Adelaide | South Australia | 05065 | Australia |
| Hobart Hospital-Royal Hobart Hospital | Recruiting | Hobart | Tasmania | 07000 | Australia |
| Cancer Research Sa (Crsa) | Recruiting | Adelaide | 05000 | Australia |
| Southern Oncology Clinical Research Unit | Withdrawn | South Australia | 05042 | Australia |
| Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet | Recruiting | Brussels | 01070 | Belgium |
| Cliniques Universitaires St Luc Ucl | Recruiting | Brussels | B-1200 | Belgium |
| Az Groeninge | Recruiting | Kortrijk | 08500 | Belgium |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 03000 | Belgium |
| Chu Liege | Not yet recruiting | Liège | 04000 | Belgium |
| Hyogo Cancer Center | Recruiting | Akashi-shi | 673-8558 | Japan |
| Saitama Medical University International Medical Center | Recruiting | Hidaka-shi | 350-1298 | Japan |
| The Cancer Institute Hospital of Jfcr | Recruiting | Kōtoku | 135-8550 | Japan |
| Kurume University Hospital | Recruiting | Kurume | 830-0011 | Japan |
| Shikoku Cancer Center | Recruiting | Matsuyama | 791-0280 | Japan |
| Hokkaido University Hospital | Recruiting | Sapporo | 060-8648 | Japan |
| Shizuoka Cancer Center | Recruiting | Sunto-gun | 411-8777 | Japan |
| Panoncology Trials | Recruiting | San Juan | PR | 00935 | Puerto Rico |
| Hospital Universitario Vall D'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Instituto Catalan de Oncologia - Hospital Duran I Reynals | Not yet recruiting | Barcelona | 08908 | Spain |
| Hospital Universitario Reina Sofia | Not yet recruiting | Córdoba | 14004 | Spain |
| Institut Catala D'Oncologia Girona | Recruiting | Girona | 17007 | Spain |
| Clinica Universidad de Navarra - Sede Madrid | Recruiting | Madrid | 28027 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de La Arrixaca | Recruiting | Murcia | 30120 | Spain |
| Fundacion Instituto Valenciano de Oncologia | Recruiting | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva) | Recruiting | Valencia | 46010 | Spain |
| Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona | Recruiting | Bellinzona | 06500 | Switzerland |
| Kantonsspital Graubunden | Not yet recruiting | Chur | 07000 | Switzerland |
| Geneva University Hospitals-Hug | Recruiting | Geneva | 01211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit | Recruiting | Lausanne | 01011 | Switzerland |
| Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust | Recruiting | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust | Recruiting | London | SM2 5PT | United Kingdom |
| Hammersmith Hospital - Imperial College Healthcare Nhs Trust | Recruiting | London | W12 0HS | United Kingdom |
| The Christie Nhs Foundation Trust | Recruiting | Manchester Greater | M204BX | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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