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

Platinum-sensitive Relapsed Ovarian Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03705156
• Other study ID #: ZL-2306-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 8, 2017
• Est. completion date: August 24, 2024

Study information

• Verified date: April 2023
• Source: Zai Lab (Hong Kong), Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 265
• Est. completion date: August 24, 2024
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Neoplasms
• Platinum-sensitive Relapsed Ovarian Cancer

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zai Lab (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Overall survival (OS)	It refers to the time from the date of randomization to death for any cause.	35 months