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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 FRĪ±, 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group A (TGA) 		INCB123667 at the protocol-defined dose.
  • Drug: INCB123667
    Oral; tablet
Experimental
Treatment Group B (TGB) 		Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.
  • Drug: Investigator's choice of chemotherapy
    The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
    Other names:
    • paclitaxel
    • pegylated liposomal doxorubicin (PLD)
    • gemcitabine
    • topotecan

Recruiting Locations

Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.