Trials / Terminated
TerminatedNCT03891576
Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)
A Multicenter, Open-label Phase II Trial of a New Customized Dosing (RADAR Dosing) of Niraparib As Maintenance Therapy in Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Recurrent Cancer Patients
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Mario Negri Institute for Pharmacological Research · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors. |
Timeline
- Start date
- 2019-11-13
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
- First posted
- 2019-03-27
- Last updated
- 2025-01-17
Locations
12 sites across 2 countries: Germany, Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03891576. Inclusion in this directory is not an endorsement.