NCT04169997

A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

A Phase III Study to Evaluate the Efficacy and Safety of IMP4297 Following 1st Line Chemotherapy in the Monotherapy Maintenance Treatment of Subjects With Ovarian Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Impact Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IMP4297 is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of IMP4297 for Maintenance Treatment

Detailed description

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IMP4297 Following First-Line Platinum-based Chemotherapy in the Monotherapy Maintenance Treatment . The Subjects with newly diagnosed, histologically confirmed FIGO stage lll-IV high grade serous, high grade endometrioid or BRCA mutant other histological types of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have had a complete/partial response (CR/PR) after first-line platinum-based therapy will be randomly assigned to IMP4297 or placebo at a 2:1 ratio.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	IMP4927	IMP4297 tablet.The starting dose from 100mg QD
DRUG	Placebos	Placebos tablet.The starting dose from 100mg QD

Timeline

• Start date: 2019-12-24
• Primary completion: 2023-03-16
• Completion: 2026-06-30
• First posted: 2019-11-20
• Last updated: 2026-01-28

Locations

2 sites across 1 country: China