Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting

Sponsor
The University of Hong Kong
Study ID
NCT04284852
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study aims to evaluate the effects of niraparib in those who have received neoadjuvant chemotherapy and subsequent interval debulking surgery, with or without hyperthermic intraperitoneal chemotherapy, and would also explore if there are any biomarkers, other than BRCA / HRD status and platinum sensitivity, that may help to identify those who may benefit from PARPi especially those who are HRD negative.

Key Dates

Start date
May 1, 2020
Status verified
Oct 2023
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Niraparib 200 or 300mg daily orally for 18 cycles unless disease progression or intolerable side effects (whichever occurs first)

Primary Outcome Measure

PFS rate at 18 months [ Time Frame: up to 18 months ]

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