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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-08

Study Completion Date

2022-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No