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

Primary Purpose

Platinum-sensitive Relapsed Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ZL-2306(nirapairb)
Placebos
Sponsored by
Zai Lab (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum-sensitive Relapsed Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZL-2306

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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);
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.
Overall survival (OS)
It refers to the time from the date of randomization to death for any cause.

Full Information

First Posted
September 19, 2018
Last Updated
April 12, 2023
Sponsor
Zai Lab (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03705156
Brief Title
Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
August 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zai Lab (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-sensitive Relapsed Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZL-2306
Arm Type
Experimental
Arm Description
The starting dose is 300 mg or 200 mg based on patient's body weight.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
Intervention Type
Drug
Intervention Name(s)
ZL-2306(nirapairb)
Intervention Description
The starting dose is 300 mg or 200 mg based on patient's body weight.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
35 months
Secondary Outcome Measure Information:
Title
Chemotherapy-free interval (CFI)
Description
It refers to the time from the last platinum-containing treatment to the start of the next anti-cancer treatment (excluding maintenance treatment);
Time Frame
35 months
Title
Time to first subsequent anti-cancer treatment (TFST)
Description
It refers to the time from the date of randomization in the study to the date when the first subsequent anti-tumor treatment starts.
Time Frame
35 months
Title
Overall survival (OS)
Description
It refers to the time from the date of randomization to death for any cause.
Time Frame
35 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Cancer center of Guangzhou medical university
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Harbin Medical university cancer hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
the first affiliated hospital of of Harbin medical university
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital Central South Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hunan
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The first Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shaanxi Cancer Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
West China second university hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Affiliate Cancer Hospital Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Woman's hospital School of medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Cancer hospital Chinese academy of medical science
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University People's hospital
City
Beijing
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Name
Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Tianjin Tumour Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33453391
Citation
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.
Results Reference
derived

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

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