Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study

• Conditions: Ovarian Cancer

• Registration Number: NCT04617470
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.

Detailed Description

This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. Will be enrolled all patients who have been part of the Italian Compassionate Use Program (CUP) prior to participating in this study. Once the CUP will be closed the trial will continue with th prospective collection of data of patients treated with Niraparib according to the label for 2 years.

Study Timeline

• Study Start: 2020-07-08
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-11-01
• Study First Posted: 2020-11-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• patients that received niraparib as monotherapy for the maintenance treatment of platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after response (complete or partial) to platinum-based chemotherapy as part of the CUP, regardless of whether the patient is receiving niraparib at the time of enrolment;
• patients with high grade serous ovarian cancer treated with Niraparib according to the label will be included;
• patients able to understand the study procedures and that agree to participate in the study by providing written informed consent

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	up to two years	To compare PFS of patients with advanced, platinum sensitive ovarian cancer treated with Niraparib as maintenance treatment

Secondary Outcome Measures

Name	Time	Method
ORR	up to two years	Overall Response Rate
TSST	up to two years	Time to second subsequent therapy
OS	up to two years	Overall Survival
Incidence of treatment-emergent adverse events	up to two years	Toxicity will be evaluated by NCI CTCAE V 4.03
TFST	up to two years	Time to first subsequent therapy

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy