Ovarian Cancer
Conditions
Interventions
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 investigato
Sponsors
Ono Shintaro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. 2. 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. 3. 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. 4. 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. 5. Should have received prior treatment with bevacizumab unless there was a contraindication for its use. 6. Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FR-alpha, unless there is an exception for its use on medical grounds. 7. Measurable disease per RECIST v1.1.
Exclusion criteria
Exclusion criteria: 1. Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer. 2. Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy. 3. Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment. 4. Known active CNS metastases and/or carcinomatous meningitis. 5. 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. 6. Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-Free Survival (PFS) by BICR [Time Frame: Up to 2 years] 2. Overall Survival (OS) [Time Frame: Up to 2 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response by BICR [Time Frame: Up to 2 years] 2. Duration of Response (DOR) by BICR [Time Frame: Up to 2 years] 3. Progression-Free Survival (PFS) by investigator [Time Frame: Up to 2 years] 4. Objective response by investigator [Time Frame: Up to 2 years] 5. DOR by investigator [Time Frame: Up to 2 years] 6. Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 2 years and 30 days] 7. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time Frame: Up to 2 years and 30 days] 8. 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] 9. 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] 10. Change from baseline in EQ-5D-5L score at each postbaseline visit [Time Frame: Up to 2 years] | — |
Countries
Japan, To be determined
Contacts
Public ContactMedical Information Center
Incyte Biosciences Japan G.K.
Outcome results
None listed