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

NCT03705156 | Unknown Phase 3

• 1 other identifier: ZL-2306-001
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 27

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Chemotherapy-free interval (CFI)

  35 months

• Time to first subsequent anti-cancer treatment (TFST)

  35 months

• Overall survival (OS)

  35 months

Study Arms (2)

ZL-2306

EXPERIMENTAL

The starting dose is 300 mg or 200 mg based on patient's body weight.

Drug: ZL-2306(nirapairb)

Placebo

PLACEBO COMPARATOR

The starting dose is the matched dose of placebo (3 capsules or 2 capsules).

Drug: Placebos

Interventions

ZL-2306(nirapairb) DRUG

The starting dose is 300 mg or 200 mg based on patient's body weight.

ZL-2306

Placebos DRUG

The starting dose is the matched dose of placebo (3 capsules or 2 capsules).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (27)

Cancer center of Guangzhou medical university

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Harbin Medical university cancer hospital

Harbin, Heilongjiang, China

Location

the first affiliated hospital of of Harbin medical university

Harbin, Heilongjiang, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Xiangya Hospital Central South Hospital

Changsha, Hunan, China

Location

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hunan, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

The first Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Location

Shaanxi Cancer Hospital

Xi'an, Shaanxi, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

West China second university hospital

Chengdu, Sichuan, China

Location

Affiliate Cancer Hospital Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

Woman's hospital School of medicine Zhejiang University

Hangzhou, Zhejiang, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Cancer hospital Chinese academy of medical science

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University People's hospital

Beijing, China

Location

Chongqing Cancer Hospital

Chongqing, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China

Location

Tianjin Tumour Hospital

Tianjin, China

Location

Related Publications (2)

• Wu X, Zhu J, Yin R, Yang J, Liu J, Wang J, Wu L, Liu Z, Gao Y, Wang D, Lou G, Yang H, Zhou Q, Kong B, Huang Y, Chen L, Li G, An R, Wang K, Zhang Y, Yan X, Lu X, Lu W, Hao M, Wang L, Cui H, Chen Q, Abulizi G, Huang X, Tian X, Wen H, Huang Z, Dong J, Zhang C, Hou J, Mirza MR. Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial. EClinicalMedicine. 2024 May 7;72:102629. doi: 10.1016/j.eclinm.2024.102629. eCollection 2024 Jun.

  PMID: 38745967 DERIVED

• 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.

  PMID: 33453391 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: October 15, 2018
• Study Start: June 8, 2017
• Primary Completion: February 1, 2020
• Study Completion: August 24, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (27)