A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508010-42-00

Acronym

PR-30-5017-C

Enrollment

469

Registered

2024-05-13

Start date

2016-09-14

Completion date

2025-09-30

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homologous recombination deficiency advanced ovarian cancer

Brief summary

The primary endpoint is PFS, defined as the time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.

Detailed description

The secondary endpoints include the following: • OS • Observed changes from baseline in the following PROs: − FOSI − EQ-5D-5L − EORTC-QLQ-C30 − EORTC-QLQ-OV28 • Time to first subsequent therapy (TFST) • PFS2

Interventions

DRUGPlacebo with a matching appearance to 100 mg niraparib capsules

DRUGfilled with an excipient blend for clinical development.

DRUGNIRAPARIB TOSILATE MONOHYDRATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is PFS, defined as the time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.	—

Secondary

Measure	Time frame
The secondary endpoints include the following: • OS • Observed changes from baseline in the following PROs: − FOSI − EQ-5D-5L − EORTC-QLQ-C30 − EORTC-QLQ-OV28 • Time to first subsequent therapy (TFST) • PFS2	—

Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026