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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZL-2306 | Experimental | The starting dose is 300 mg or 200 mg based on patient's body weight. |
|
| Placebo | Placebo Comparator | The starting dose is the matched dose of placebo (3 capsules or 2 capsules). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-2306(nirapairb) | Drug | The starting dose is 300 mg or 200 mg based on patient's body weight. |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer center of Guangzhou medical university | Guangzhou | Guangdong | China | |||
| Sun Yat-sen University Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38745967 | Derived | 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. | |
| 33453391 |
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| Placebos |
| Drug |
The starting dose is the matched dose of placebo (3 capsules or 2 capsules). |
|
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 |
| 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 |
| 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. |