Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient
NCT ID: NCT03705156
Last Updated: 2023-04-13
Study Results
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Basic Information
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UNKNOWN
PHASE3
265 participants
INTERVENTIONAL
2017-06-08
2024-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZL-2306
The starting dose is 300 mg or 200 mg based on patient's body weight.
ZL-2306(nirapairb)
The starting dose is 300 mg or 200 mg based on patient's body weight.
Placebo
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
Placebos
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
FEMALE
No
Sponsors
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Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer center of Guangzhou medical university
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical university cancer hospital
Harbin, Heilongjiang, China
the first affiliated hospital of of Harbin medical university
Harbin, Heilongjiang, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South Hospital
Changsha, Hunan, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The first Bethune Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shaanxi Cancer Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
West China second university hospital
Chengdu, Sichuan, China
Affiliate Cancer Hospital Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Woman's hospital School of medicine Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 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
Chongqing Cancer Hospital
Chongqing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, , China
Tianjin Tumour Hospital
Tianjin, , China
Countries
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References
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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.
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.
Other Identifiers
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ZL-2306-001
Identifier Type: -
Identifier Source: org_study_id
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