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

NCT03705156 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2023-04-13

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2020-02-01
Completion
2024-08-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705156 on ClinicalTrials.gov