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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Platinum-sensitive Relapsed Ovarian Cancer

Intervention / Treatment
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* Drug: ZL-2306(nirapairb)
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older female. High-grade serous or dominantly high-grade serous ovarian cancer The subject shall have received two lines of platinum-containing chemotherapy, complete response [CR] or partial response [PR] after first-line platinum-containing chemotherapy, and after received at least 4 cycles of platinum-containing (must be carboplatin or cisplatin or nedaplatin) in second-line platinum-containing chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Patients who have undergone ascites drainage with the last two cycles of the last chemotherapy regimen prior to enrollment. Symptomatic brain metastases or leptomeningeal metastases that have not been controlled. Patients who have been diagnosed previously or currently with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZL-2306<br>The starting dose is 300 mg or 200 mg based on patient's body weight. | Drug: ZL-2306(nirapairb)<br>* The starting dose is 300 mg or 200 mg based on patient's body weight.<br>|
| Placebo Comparator: Placebo<br>The starting dose is the matched dose of placebo (3 capsules or 2 capsules). | Drug: Placebos<br>* The starting dose is the matched dose of placebo (3 capsules or 2 capsules).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | It is defined as the time from randomization to progressive disease or death due to various causes, whichever occurs first. Progressive disease will be determined by the Independent Central Imaging Review according to standard RECIST 1.1. | 35 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy-free interval (CFI) | It refers to the time from the last platinum-containing treatment to the start of the next anti-cancer treatment (excluding maintenance treatment); | 35 months | 
| Time to first subsequent anti-cancer treatment (TFST) | It refers to the time from the date of randomization in the study to the date when the first subsequent anti-tumor treatment starts. | 35 months | 
| Overall survival (OS) | It refers to the time from the date of randomization to death for any cause. | 35 months |