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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07546500 | A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression | PHASE3 | RECRUITING | 420 | — | — | Apr 17, 2026 | Apr 30, 2030 | May 19, 2026 | 58 | United States, Australia +10 |
Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent schedule | EXPERIMENTAL | - |
| Experimental: Arm C Investigator's choice of chemotherapy at the dose defined by the protocol | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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: * Paclitaxel * Gemcitabine * Pegylated liposomal doxorubicin (PLD) * Topotecan The selected chemotherapy will be administered intravenously |
| Azenosertib | DRUG | Azenosertib 400 mg will be administered orally. |
Inclusion Criteria: 1. Female age ≥ 18 years 2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Measurable disease per RECIST Version 1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 5. The subject's tumor tissue must be positive fo...