Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07214779 | Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression | PHASE3 | RECRUITING | 466 | — | — | Dec 9, 2025 | May 14, 2029 | Jun 1, 2026 | 167 | United States, Australia +13 |
| NCT07023627 | A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression | PHASE2 | RECRUITING | 160 | — | — | Nov 12, 2025 | Oct 24, 2027 | Jun 1, 2026 | 79 | United States, Australia +6 |
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.
Defined as the time from the date of randomization until death due to any cause.
Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A (TGA) | EXPERIMENTAL | INCB123667 at the protocol-defined dose. |
| Treatment Group B (TGB) | EXPERIMENTAL | Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol. |
| Cohort 1 | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
| Cohort 2 | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
| Cohort 3 | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
| Name | Type | Description |
|---|---|---|
| INCB123667 | DRUG | Oral; tablet |
| Investigator's choice of chemotherapy | DRUG | The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: |
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 reg...