drugset / Trial / NCT04159155

A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer

NCT04159155

Phase 2/3 Terminated 11 enrolled University Health Network, Toronto
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an umbrella, two-arm, multi-stage, phase II trial. The purpose of the trial in the early stage cohort is to determine if EBRT improves disease free survival (defined as the time from random assignment to disease recurrence or death from any cause) compared to vaginal brachytherapy after chemotherapy in women with serous or p53 aberrant endometrial cancer. The purpose of the trial in the advanced stage cohort is to determine if the maintenance with experimental treatment increases progression free survival, defined as the time from random assignment to disease progression or death from any cause.

Timeline

Start
2020-11-17
Primary completion
2025-05-26
Completion
2025-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule 200 mg Oral
Subject Niraparib Small molecule 300 mg Oral