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

Ovarian Cancer Clinical Trial

— MITO 34  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617470
• Other study ID #: 2487
• Status: Recruiting
• Start date: July 8, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Domenica Lorusso, MD
• Phone: 0630158545
• Email: domenica.lorusso[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	GlaxoSmithKline

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	To compare PFS of patients with advanced, platinum sensitive ovarian cancer treated with Niraparib as maintenance treatment	up to two years
Secondary	TFST	Time to first subsequent therapy	up to two years
Secondary	TSST	Time to second subsequent therapy	up to two years
Secondary	OS	Overall Survival	up to two years
Secondary	ORR	Overall Response Rate	up to two years
Secondary	Incidence of treatment-emergent adverse events	Toxicity will be evaluated by NCI CTCAE V 4.03	up to two years