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Набира участници Фаза 2 NCT07023627

A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Ovarian Cancer

Спонсор: Incyte Corporation

Налично на: БГ
Обобщение
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Кой може да участва
Inclusion Criteria: * 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. Exclusion Criteria: * 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: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy. * The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication. * Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug. * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or requires active treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Места на провеждане 8
Австралия (1)
Blacktown Cancer & Haematology Centre-Blacktown Hospital
Blacktown , New South Wales
NOT_YET_RECRUITING
Белгия (1)
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels
Япония (1)
Hyogo Cancer Center
Akashi-shi
Puerto Rico (1)
Panoncology Trials
San Juan , PR
Испания (1)
Hospital Universitario Vall D'Hebron
Barcelona
NOT_YET_RECRUITING
Швейцария (1)
Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona
Bellinzona
NOT_YET_RECRUITING
Великобритания (1)
St Bartholomew'S Hospital
London
NOT_YET_RECRUITING
САЩ (1)
Usa Health Mitchell Cancer Institute
Mobile , Alabama
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
12.11.2025
Крайна дата
24.10.2027
Регистрационен номер
NCT07023627
Източник
anzctr
Запитване за медицински туризъм

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