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Study for Platinum-Resistant Ovarian Cancer with Cyclin E1 Overexpression

This study is testing a new oral drug called INCB123667 against standard chemotherapy options for women with platinum-resistant ovarian cancer. Platinum-resistant means the cancer has grown or returned within six months after platinum-based chemotherapy. You might be able to join if you have high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum-resistant, and your cancer shows high levels of a protein called cyclin E1. The study aims to see if INCB123667 can stop the cancer from growing for longer (Progression-Free Survival) and help people live longer (Overall Survival) compared to standard chemotherapy. The study plans to enroll 466 participants, but its current recruitment status is unclear.

Study design
This study is comparing INCB123667 to chemotherapy chosen by your doctor. It plans to include 466 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for up to 2 years to see how long the cancer is controlled and how long you live.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214779

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Incyte Corporation
~466 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:INCB123667Investigator's choice of chemotherapy

At a glance

Recruiting sites
28 of 181 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) by BICR
Measured over Up to 2 years
+1 more outcome measured

Conditions

Ovarian Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerG1/S-Specific Cyclin-E1

Where it's being run

181 sites across 44 states
Italy19
Japan15
South Korea15
United Kingdom13
France12
Spain11
Germany9
California6

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.

What this trial measures

  • Progression-Free Survival (PFS) by BICRUp to 2 years

    Defined as the time from the date of randomization until the earliest date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.

  • Overall Survival (OS)Up to 2 years

    Defined as the time from the date of randomization until death due to any cause.