NCT03709316

A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer) Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Niraparib 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 ZL-2306 (Niraparib) for Maintenance Treatment

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	ZL-2306 (Nirapairb)	The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
DRUG	Placebo Comparator	The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Timeline

• Start date: 2018-06-30
• Primary completion: 2022-01-29
• Completion: 2023-12-30
• First posted: 2018-10-17
• Last updated: 2021-06-02

Locations

31 sites across 1 country: China