Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Phase 3 – large-scale trial before approval
Conditions:
Ovarian Cancer
Sponsor: Incyte Corporation
trial.available_in:
БГ
Overview
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.
Who can participate
Inclusion Criteria:
* 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.
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, 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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Locations
15
Australia (1)
Chris O'Brien Lifehouse Hospital
Camperdown , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels
NOT_YET_RECRUITING
Canada (1)
Arthur J E Child Comprehensive Cancer Centre
Calgary , Alberta
NOT_YET_RECRUITING
France (1)
Ch Davignon - Hopital Henri Duffaut
Avignon
NOT_YET_RECRUITING
Germany (1)
Universitätsklinikum Bonn
Bonn
NOT_YET_RECRUITING
Ireland (1)
St. Vincent'S University Hospital
Dublin
NOT_YET_RECRUITING
Italy (1)
Ss Antonio & Biagio and C. Arrigo Hospital
Alessandria
NOT_YET_RECRUITING
Japan (1)
Hyogo Cancer Center
Akashi-shi
NOT_YET_RECRUITING
Netherlands (1)
Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)
Amsterdam
NOT_YET_RECRUITING
Poland (1)
Uniwersyteckie Centrum Onkologii
Bialystok
NOT_YET_RECRUITING
South Korea (1)
National Cancer Center
Gyeonggi-do
NOT_YET_RECRUITING
Spain (1)
Hospital Universitario de Alava
Alava
NOT_YET_RECRUITING
Switzerland (1)
Ospedale Regionale Di Bellinzona
Bellinzona
NOT_YET_RECRUITING
United Kingdom (1)
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust