Platinum-sensitive Relapsed Ovarian Cancer
Conditions
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.
Interventions
The starting dose is 300 mg or 200 mg based on patient's body weight.
DRUGPlacebos
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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); |
| 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. |
Countries
China
Outcome results
None listed