Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study (MITO 34)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Unknown

Conditions

Ovarian Cancer

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04617470
2487

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Serena Giolitto, MSc; Domenica Lorusso, MD

Data sourced from clinicaltrials.gov

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