Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Key facts
- Where
- Alba, Alexandria, Aviano, Bologna, Florence, Lecco, Milan, Naples, Padova, Pavia, Piacenza, Ravenna, Rome, Treviso, Turin, Udine és Venice, OlaszországSee the 20 sites
- Phase
- 3. fázis
Where in Olaszország
- Azienda Sanitaria Locale Cn2 Alba-BraAlba, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo AlessandriaAlexandria, OlaszországNo longer taking part
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria CareggiFlorence, OlaszországNo longer taking part
- Alessandro Manzoni HospitalLecco, OlaszországNo longer taking part
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországNo longer taking part
- Humanitas Mirasole S.p.A.Milan, OlaszországNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországNo longer taking part
- Istituto Oncologico VenetoPadova, OlaszországNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországNo longer taking part
- Azienda Unita Sanitaria Locale Di PiacenzaPiacenza, OlaszországNo longer taking part
- Azienda Unità Sanitaria Locale della RomagnaRavenna, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
- I.F.O. Istituti Fisioterapici OspitalieriRome, OlaszországNo longer taking part
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaTreviso, OlaszországNo longer taking part
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, OlaszországNo longer taking part
- Azienda Sanitaria Universitaria Friuli CentraleUdine, OlaszországNo longer taking part
- Azienda Ulss 3 SerenissimaVenice, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07214779EU 2025-522748-42-00
- Record updated
- 2026. október 15.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment; 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; 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; Known active CNS metastases and/or carcinomatous meningitis; Clinically significant gastrointestinal abnormalities; Other protocol-defined Inclusion/Exclusion Criteria may apply.