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NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.

NCT03752216 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-12-13

No results posted yet for this study

Summary

This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.

Conditions

Interventions

DRUG

Niraparib

Two different doses of Niraparib can be administrated: For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules. For patient who had at baseline (T0) a body weight \< 77 kg or a platelet count \<150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules. Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria.

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • ARCAGY/ GINECO GROUP

    lead OTHER

Principal Investigators

  • Florence JOLY, MD, PhD · Centre François Baclesse 3, avenue du Général Harris 14076 CAEN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2021-08-18
Completion
2022-12-13

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752216 on ClinicalTrials.gov