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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06594679 | A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) | PHASE1 | RECRUITING | 73 | — | — | Sep 26, 2024 | Sep 18, 2027 | Mar 28, 2025 | 1 | Italy |
This is a dose-escalation study of niraparib plus abemaciclib followed by an efficacy study for late-line treatment of ovarian cancer
Maximum tolerated dose (MTD) of niraparib in combination with abemaciclib in patients with advanced ovarian cancer defined as the dose level immediately below the dose at which ≥ 33% of patients experience dose-limiting toxicity as defined by protocol according to CTCAE 5.0
proportion of patients whose disease shrinks (i.e. complete or partial response) or remains stable over 16 weeks after the start of niraparib + abemaciclib combination. Revised RECIST 1.1 criteria will be used to assess tumor response
| Arm | Type | Description |
|---|---|---|
| ARM 1 | EXPERIMENTAL | Niraparib+Abemaciclib |
| Name | Type | Description |
|---|---|---|
| Niraparib Tosylate Monohydrate | DRUG | Combination of niraparib and abemaciclib |
Inclusion Criteria: * Has read and understands the informed consent form and has given written informed consent prior to any study procedures. * Age \> 18 years * Life expectancy of at least 3 months * Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer * Confi...