Clinical trial NCT03705156: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Platinum-sensitive Relapsed Ovarian Cancer
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 35 months
Secondary outcomes:
measure: Chemotherapy-free interval (CFI)
timeFrame: 35 months
measure: Time to first subsequent anti-cancer treatment (TFST)
timeFrame: 35 months
measure: Overall survival (OS)
timeFrame: 35 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer center of Guangzhou medical university
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical university cancer hospital
state: Heilongjiang
city: Harbin
country: China
facility: the first affiliated hospital of of Harbin medical university
state: Heilongjiang
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South Hospital
state: Hunan
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first Bethune Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Xi'an
country: China
facility: Shaanxi Cancer Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Chengdu
country: China
facility: West China second university hospital
state: Sichuan
city: Urumqi
country: China
facility: Affiliate Cancer Hospital Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Woman's hospital School of medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Cancer hospital Chinese academy of medical science
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University People's hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
city: Tianjin
country: China
facility: Tianjin Tumour Hospital
Study officials:
References:
citation: 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.