Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

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

NCT ID: NCT07214779Sponsor: Incyte CorporationLast updated: 2026-06-01

Summary

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.

Arms & interventions

  • DrugINCB123667

    Oral; tablet

  • DrugInvestigator'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:

Outcome measures

Primary

  • Progression-Free Survival (PFS) by BICR

    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.

    Time frame: Up to 2 years

  • Overall Survival (OS)

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

    Time frame: Up to 2 years

Secondary

  • Objective response by BICR

    Time frame: Up to 2 years

  • Duration of Response (DOR) by BICR

    Time frame: Up to 2 years

  • Progression-Free Survival (PFS) by investigator

    Time frame: Up to 2 years

  • Objective response by investigator

    Time frame: Up to 2 years

  • DOR by investigator

    Time frame: Up to 2 years

  • Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 2 years and 30 days

  • TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment

    Time frame: Up to 2 years and 30 days

  • Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit

    Time frame: Up to 2 years

  • Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 28 (C28) score at each postbaseline visit

    Time frame: Up to 2 years

  • Change from baseline in EQ-5D-5L score at each postbaseline visit

    Time frame: Up to 2 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy 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 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.

Study locations (29)

Alaska Womens Cancer Care Akwcc

Anchorage, Alaska, 99508

Not Yet Recruiting

City of Hope Medical Center

Duarte, California, 91010

Not Yet Recruiting

University of California, San Diego-Moores Cancer Center

La Jolla, California, 92037

Not Yet Recruiting

Valkyrie Clinical Trials

Los Angeles, California, 90067

Recruiting

University of Colorado Cancer Center

Aurora, Colorado, 80045

Not Yet Recruiting

Georgia Cancer Center

Augusta, Georgia, 30912

Not Yet Recruiting

Carle Cancer Center

Effingham, Illinois, 62401-2006

Not Yet Recruiting

Northshore University Health System-Evanston Hospital

Evanston, Illinois, 60201

Not Yet Recruiting

Women'S Cancer Care

Covington, Louisiana, 70433

Not Yet Recruiting

Maine Center For Cancer Medicine

Scarborough, Maine, 04074

Not Yet Recruiting

Holy Cross Hospital

Silver Spring, Maryland, 20910

Not Yet Recruiting

Mercy Hospital St. Louis - David C. Pratt Cancer Center

St Louis, Missouri, 63141

Not Yet Recruiting

Billings Clinic

Billings, Montana, 59101

Recruiting

Center of Hope

Reno, Nevada, 89511

Not Yet Recruiting

Ny Cancer and Blood Specialists

Shirley, New York, 11967

Withdrawn

Levine Cancer Center

Charlotte, North Carolina, 28204

Not Yet Recruiting

Novant Presbyterian Hospital

Charlotte, North Carolina, 28204

Not Yet Recruiting

Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103

Not Yet Recruiting

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

Not Yet Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Not Yet Recruiting

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401

Not Yet Recruiting

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213

Not Yet Recruiting

University of Pittsburgh Cancer Institute Cancer Services

Pittsburgh, Pennsylvania, 15213

Not Yet Recruiting

Wellspan Gynecologic Oncology

York, Pennsylvania, 17403

Not Yet Recruiting

Sanford Cancer Center-Sioux Falls

Sioux Falls, South Dakota, 57104-8805

Not Yet Recruiting

Erlanger Health, Inc.

Chattanooga, Tennessee, 37403

Recruiting

Texas Oncology-Abilene

Abilene, Texas, 79606

Not Yet Recruiting

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

Not Yet Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Not Yet Recruiting
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression | Cancerify