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Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

NCT07214779

RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: Ovarian Cancer

Interventions: INCB123667, Investigator's choice of chemotherapy

Countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Italy

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (181)

Anchorage, Alaska, United States
Tucson, Arizona, United States
Duarte, California, United States
Fullerton, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Oxnard, California, United States
Aurora, Colorado, United States
Miramar, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Effingham, Illinois, United States
Evanston, Illinois, United States
Zion, Illinois, United States
Edgewood, Kentucky, United States
Covington, Louisiana, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Silver Spring, Maryland, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
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