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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIncyte Corporation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • INCB123667
  • Investigator's choice of chemotherapy

Treatment groups

466 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Incyte Corporation

Lead sponsor

ENGOT Foundation

Collaborator

GOG Foundation

Collaborator