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

Locations

172
Australia
Chris O'Brien Lifehouse Hospital02050, CamperdownNew South Wales, Australia
North Coast Cancer Institute02444, Port MacquarieNew South Wales, Australia
The Wollongong Hospital02500, WollongongNew South Wales, Australia
Icon Cancer Care - Townsville04812, TownsvilleQueensland, Australia

Sponsors and collaborators

Incyte Corporation

Lead sponsor

ENGOT Foundation

Collaborator

GOG Foundation

Collaborator