A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer
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 Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer) Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy
1 other identifier
interventional
384
1 country
31
Brief Summary
Niraparib is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started Jun 2018
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJune 2, 2021
May 1, 2021
3.6 years
September 19, 2018
May 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
BICR-assessed progression-free survival (PFS)
the time from randomization to progressive disease or death due to various causes assessed by the BICR according to RECIST 1.1, whichever occurs first
Approximately 36 months since the first subject enrolled
Secondary Outcomes (3)
Overall survival (OS)
Approximately 36 months since the first subject enrolled
Time to first subsequent anti-tumor treatment (TFST)
Approximately 36 months since the first subject enrolled
PFS and OS assessed by BICR in patients with HRD (homologous recombination defects)
Approximately 36 months since the first subject enrolled
Study Arms (2)
ZL-2306 (Nirapairb)
EXPERIMENTALThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Placebo
PLACEBO COMPARATORThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Interventions
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Eligibility Criteria
You may qualify if:
- \. The written informed consent form shall be signed before proceeding with any study-related procedure.
- \. The subject agrees to collection of blood samples for detection of gBRCA mutations (gBRCA mutation status must be known before randomization).
- \. The subject shall be a female, aged 18 years or older.
- \. Histologically confirmed high-grade serous/endometrioid or dominantly high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma (no histological restriction for patients carrying germline BRCA mutations).
- Note: Patients who have received neoadjuvant chemotherapy can also be enrolled if their tumors after chemotherapy cannot be pathologically graded.
- \. FIGO staging is Stage III or IV.
- \. Criteria for previous surgery (meeting any of these):
- Inoperable Stage III or IV patients
- Stage IV patients, regardless of postoperative residual lesion status
- Stage III patients who have undergone primary tumor reductive surgery with postoperative residual lesion status of R1 (microscopic residual lesions) or R2 (macroscopic residual lesions)
- Stage III or IV patients who have undergone intermittent tumor reductive surgery (patients who have used neoadjuvant therapy) regardless of postoperative residual lesion status
- \. Criteria for previous chemotherapy:
- It is allowed to enroll patients who have received intraperitoneal chemotherapy
- Patients have completed at least 6 cycles yet no more than 9 cycles of first-line platinum-containing chemotherapy (preferably carboplatin, but cisplatin is also acceptable)
- Patients undergoing intermittent tumor reductive surgery should respectively receive at least 2 cycles of platinum-containing chemotherapy preoperatively and postoperatively, and receive a total of at least 6 cycles yet no more than 9 cycles of chemotherapy (preferably carboplatin, but cisplatin is also acceptable) preoperatively and postoperatively
- +17 more criteria
You may not qualify if:
- \. Patients diagnosed with mucinous, clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, or undifferentiated ovarian cancer.
- \. Stage III patients who have undergone primary tumor reductive surgery with postoperative status of R0-complete resection (with no residual lesion).
- \. Patients who have undergone tumor reductive surgery more than twice.
- \. Patients who plan to or have used bevacizumab as maintenance therapy after first-line platinum-containing chemotherapy. If the patient received bevacizumab in platinum-containing chemotherapy but did not receive bevacizumab as maintenance therapy, and the last dose of bevacizumab was used ≥ 28 days before signing the master informed consent form, the patient can be enrolled.
- \. Patients who are known to be allergic to active or inactive ingredients of ZL-2306 (niraparib) or other drugs with similar chemical structures to ZL-2306 (niraparib).
- \. Patients who have previously been treated with PARP inhibitors (including niraparib).
- \. Patients who have received other study drug treatment within 4 weeks prior to the first administration or \< 5 elimination half-lives of the study drug (whichever is longer).
- \. Patients with ≥ grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy for more than 4 weeks.
- \. Patients with transfusion-dependent anemia or thrombocytopenia, including:
- Patients who have received blood transfusion (platelet or red blood cell) within 2 weeks before the first dose
- Patients who have received colony stimulating factor therapy (e.g., granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), or recombinant erythropoietin) within 2 weeks before the first dose
- \. Patients who have undergone ascites drainage within 4 weeks prior to enrollment.
- \. Brain metastases or leptomeningeal metastases that have not been treated or whose symptoms have not been controlled (e.g., new or worsening symptoms or signs, or the required dose of hormones is not yet stable). Note: It is not necessary to perform an imaging scan to confirm whether there is a brain metastasis or not; patients with spinal cord compression who have received symptomatic treatment and have evidence on clinical stable status of the disease for at least 28 days could still be considered as eligible for enrollment.
- \. Patients who have received a major surgery 3 weeks before the start of the study, or is subject to any surgical effect that has not yet been recovered after surgery.
- \. Patients who have received palliative radiotherapy for \> 20% of bone marrow 3 weeks prior to enrollment.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Anhui Provincal Hospital
Hefei, Anhui, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guizhou Cancer hospital
Guiyang, Guizhou, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan hospital of wuhan university
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
second hospital of Shanxi medical university
Taiyuan, Shanxi, China
West China second university hospital
Chengdu, Sichuan, China
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, China
Affiliate Cancer Hospital Xinjiang Medical University
Ürümqi, 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
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, China
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's hospital
Beijing, China
Fudan University Shanghai Cancer Center
Shanghai, China
Tianjin Tumour Hospital
Tianjin, China
Related Publications (1)
Li N, Zhu J, Yin R, Wang J, Pan L, Kong B, Zheng H, Liu J, Wu X, Wang L, Huang Y, Wang K, Zou D, Zhao H, Wang C, Lu W, Lin A, Lou G, Li G, Qu P, Yang H, Zhang Y, Cai H, Pan Y, Hao M, Liu Z, Cui H, Yang Y, Yao S, Zhen X, Hang W, Hou J, Wang J, Wu L. Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Sep 1;9(9):1230-1237. doi: 10.1001/jamaoncol.2023.2283.
PMID: 37440217DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
October 17, 2018
Study Start
June 30, 2018
Primary Completion
January 29, 2022
Study Completion
December 30, 2023
Last Updated
June 2, 2021
Record last verified: 2021-05