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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04617470

Acronym

MITO 34

Enrollment

300

Registered

2020-11-05

Start date

2020-07-08

Completion date

2022-01-01

Last updated

2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Contacts

Primary ContactDomenica Lorusso, MD

domenica.lorusso@policlinicogemelli.it0630158545

Backup ContactSerena Giolitto, MSc

serena.giolitto@policlinicogemelli.it0630158545

Outcome results