RecruitingPhase 2NCT05961124

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

A Phase II, Single-Arm Trial Assessing Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer: Dose Escalation


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

40 participants

Start Date

Aug 21, 2023

Study Type

INTERVENTIONAL

Conditions

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?


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an alternative starting dose of niraparib — a maintenance drug used after chemotherapy for ovarian, fallopian tube, or peritoneal cancer — to see if a lower initial dose reduces the number of treatment interruptions and side effects while still maintaining effectiveness. **You may be eligible if...** - You are a woman aged 18 or older with a new diagnosis of stage III or IV high-grade ovarian, fallopian tube, or primary peritoneal cancer - You have completed at least 4 cycles of platinum-based chemotherapy with a good response - Your CA-125 tumor marker is in normal range or has dropped by 90% and stabilized - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have previously received a PARP inhibitor (such as olaparib, rucaparib, or niraparib) - You are pregnant or planning to become pregnant during the study - You have a known BRCA1 or BRCA2 gene mutation (as standard olaparib is typically offered) - You have prior hematologic toxicity grade 3 or higher, or a history of myelodysplastic syndrome - You have significant heart disease or active liver/kidney conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNiraparib

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.


Locations(1)

Sunnybrook Research Institute

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05961124


Related Trials