Trials / Recruiting
RecruitingNCT06594679
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer: a Single Center, Open Label, Single Arm, Phase Ib/II Trial NICHOL TRIAL
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an interventional trial. The goal of this clinical trial is dose finding. There are two phases: phase Ib to determine the MTD and recommended phase II dose of niraparib in combination with abemaciclib in patients with advanced ovarian cancer. Target population will be patients (woman, age \> 18 years) with epithelial ovarian, fallopian tube or peritoneal cancer treated with at least 2 lines of therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib Tosylate Monohydrate | Combination of niraparib and abemaciclib |
Timeline
- Start date
- 2024-09-26
- Primary completion
- 2027-03-20
- Completion
- 2027-09-18
- First posted
- 2024-09-19
- Last updated
- 2025-03-28
Locations
1 site across 1 country: Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06594679. Inclusion in this directory is not an endorsement.