Trials / Active Not Recruiting
Active Not RecruitingNCT04507841
Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Tongji Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who had low likelihood of achieving R0 cytoreduction by imaging assessment or laparoscopic evaluation, or cannot tolerate PDS by poor conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Neoadjuvant niraparib monotherapy with an individualized starting dose of 200mg/day or 300mg/day based on body weight or platelet count. The 28-day treatment cycle consists of 21 days of medication followed by a 7-day break. Two cycles of neoadjuvant niraparib monotherapy were used, and the investigator may choose to have an additional cycle based on the patient's condition. |
Timeline
- Start date
- 2021-01-08
- Primary completion
- 2023-09-25
- Completion
- 2026-12-31
- First posted
- 2020-08-11
- Last updated
- 2024-12-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04507841. Inclusion in this directory is not an endorsement.