drugset / Trial / NCT03983226

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

NCT03983226

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.

Timeline

Start
2019-10-18
Primary completion
2025-06
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified
Background Doxorubicin Other / unclassified
Background Gemcitabine Small molecule