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

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT05961124
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    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.

Study Details

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?

Key Dates

Start date
Aug 21, 2023
Status verified
Aug 2023
Primary completion
Sep 30, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm- Niraparib
    Oral 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, then 200 mg PO daily for the third and fourth cycle. Patients will remain on the individualized dose until either they experience an adverse event and require a dose reduction or they have disease progression.

Primary Outcome Measure

Incidence of thrombocytopenia [ Time Frame: 2 years ]

Central Contacts

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