NCT04617470

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

October 5, 2020

Last Update Submit

August 24, 2021

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • TFST

    up to two years

  • TSST

    up to two years

  • OS

    up to two years

  • ORR

    up to two years

  • Incidence of treatment-emergent adverse events

    up to two years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Domenica Lorusso, MD

CONTACT

0630158545domenica.lorusso@policlinicogemelli.it

Serena Giolitto, MSc

CONTACT

0630158545serena.giolitto@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

November 5, 2020

Study Start

July 8, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

IT(1)