Spots Global Cancer Trial Database for Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient
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Trial Identification
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 ID: NCT03705156
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Urumqi, 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
Contact Details
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