Ovarian Cancer
Conditions
Interventions
Experimental: Cohort 1
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Drug: INCB123667
Administered orally tw
Sponsors
Ono Shintaro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of a 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 a 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. Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years. 4. Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option. 5. Must have received bevacizumab unless there was a contraindication for its use. 6. If the tumor tests positive for FR-alpha, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.
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: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy. 3. The tumor tests positive for FR-alpha but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication. 4. Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug. 5. Known active CNS metastases and/or carcinomatous meningitis. 6. Known additional malignancy that is progressing or requires active treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response by IRC [Time Frame: Up to 2 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of Response (DOR) by IRC [Time Frame: Up to 2 years] 2. Progression-Free Survival (PFS) by IRC [Time Frame: Up to 2 years] 3. Overall Survival (OS) [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. PFS by Investigator [Time Frame: Up to 2 years] 7. Treatment Emergent Adverse Events (TEAE'S) [Time Frame: Up to 2 years and 30 days] 8. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time Frame: Up to 2 years and 30 days] | — |
Countries
Australia, Belgium, Japan, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactMedical Information Center
Incyte Biosciences Japan G.K.
Outcome results
None listed