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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Platinum-sensitive Relapsed Ovarian Cancer
• Intervention / Treatment: Drug: ZL-2306(nirapairb); Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Science
  • Chongqing, China
    • Chongqing Cancer Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shanghai, China
    • Obstetrics and Gynecology Hospital of Fudan University
  • Tianjin, China
    • Tianjin Tumour Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China
      • Cancer Center of Guangzhou Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin Medical University Cancer Hospital
    • Harbin, Heilongjiang, China
      • the first affiliated hospital of of Harbin medical university
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
    • Changsha, Hunan, China
      • Xiangya Hospital Central South Hospital
    • Wuhan, Hunan, China
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Cancer Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Bethune Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Liaoning cancer hospital
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Shaanxi Cancer Hospital
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiao Tong University
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Second University Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Affiliate Cancer Hospital Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Woman's hospital School of medicine Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.

Publications and helpful links

General Publications

• Wu XH, Zhu JQ, Yin RT, Yang JX, Liu JH, Wang J, Wu LY, Liu ZL, Gao YN, Wang DB, Lou G, Yang HY, Zhou Q, Kong BH, Huang Y, Chen LP, Li GL, An RF, Wang K, Zhang Y, Yan XJ, Lu X, Lu WG, Hao M, Wang L, Cui H, Chen QH, Abulizi G, Huang XH, Tian XF, Wen H, Zhang C, Hou JM, Mirza MR. Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase III trial☆. Ann Oncol. 2021 Apr;32(4):512-521. doi: 10.1016/j.annonc.2020.12.018. Epub 2021 Jan 14.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): February 1, 2020
• Study Completion (Anticipated): August 24, 2024

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Hypersensitivity; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: ZL-2306-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No