Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient
- Conditions
- Platinum-sensitive Relapsed Ovarian Cancer
- Interventions
- Drug: PlacebosDrug: ZL-2306(nirapairb)
- Registration Number
- NCT03705156
- Lead Sponsor
- Zai Lab (Shanghai) Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 265
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos The starting dose is the matched dose of placebo (3 capsules or 2 capsules). ZL-2306 ZL-2306(nirapairb) The starting dose is 300 mg or 200 mg based on patient's body weight.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 35 months 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
Name Time Method Time to first subsequent anti-cancer treatment (TFST) 35 months 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) 35 months It refers to the time from the date of randomization to death for any cause.
Chemotherapy-free interval (CFI) 35 months It refers to the time from the last platinum-containing treatment to the start of the next anti-cancer treatment (excluding maintenance treatment);
Trial Locations
- Locations (27)
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
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
the first affiliated hospital of of Harbin medical university
🇨🇳Harbin, Heilongjiang, 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
Shaanxi Cancer Hospital
🇨🇳Xi'an, Shaanxi, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shaanxi, China
The first Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
West China second university hospital
🇨🇳Chengdu, Sichuan, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Affiliate Cancer Hospital Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Woman's hospital School of medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Cancer hospital Chinese academy of medical science
🇨🇳Beijing, China
Peking University People's hospital
🇨🇳Beijing, China
Tianjin Tumour Hospital
🇨🇳Tianjin, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, China