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Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

NCT05961124 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-22

No results posted yet for this study

Summary

The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are:

What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?

Conditions

  • Ovarian Cancer
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
  • High Grade Ovarian Serous Adenocarcinoma

Interventions

DRUG

Niraparib

Niraparib (Zejula) will be administered as an oral treatment once daily (continuously in a 28-day cycle). Niraparib will be administered in a dose escalation design where patients will start at a dose of 100 mg PO daily for the first two cycles (28-days each cycle), if tolerated, the dose will be increased to 200 mg PO daily for the third and fourth cycle.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Dr. Allan Covens, MD · Sunnybrook Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2025-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT05961124 on ClinicalTrials.gov