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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
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).
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
...and 17 more locations
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.
Time frame: 35 months
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 frame: 35 months
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.
Time frame: 35 months
Overall survival (OS)
It refers to the time from the date of randomization to death for any cause.
Time frame: 35 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.