NCT03705156

Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient

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 Platinum-sensitive Relapsed Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).The evaluation will be divided into two stages: Stage I will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to Stage II during which evaluation will be performed in gBRCA mutation-positive ovarian cancer patients.

Conditions

• Platinum-sensitive Relapsed Ovarian Cancer

Interventions

Type	Name	Description
DRUG	ZL-2306(nirapairb)	The starting dose is 300 mg or 200 mg based on patient's body weight.
DRUG	Placebos	The starting dose is the matched dose of placebo (3 capsules or 2 capsules).

Timeline

• Start date: 2017-06-08
• Primary completion: 2020-02-01
• Completion: 2024-08-24
• First posted: 2018-10-15
• Last updated: 2023-04-13

Locations

27 sites across 1 country: China