- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392102
A Study of Niraparib in Patients With Relapsed Ovarian Cancer
August 26, 2022 updated by: Zai Lab (Shanghai) Co., Ltd.
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced and Relapsed Ovarian Cancer After 3 or 4 Previous Chemotherapies
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens.
Niraparib is an orally active PARP inhibitor.
Niraparib will be administered once daily continuously during a 28-day cycle.
Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG).
Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Beijing Cancer Hospital
-
Beijing, Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hospital,Sun Yat-sen University
-
-
Heilongjiang
-
Haerbin, Heilongjiang, China
- Harbin Medical University
-
-
Shanghai
-
Shanghai, Shanghai, China
- Fudan University Shanghai Cancer Center
-
-
Sichuan
-
Chengdu, Sichuan, China
- West China Second Iniversity Hospital
-
-
Zhejiang
-
Guangzhou, Zhejiang, China
- Sir Run Shaw Hospital, school of medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 1. Patients must be female and at least 18 years of age
- 2. Patients must provide written informed consent
- 3. Patients must be gBRCA mutation or HRD positive
- 4. Patients must have histologically diagnosed high-grade (Grade 2 or 3)serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease.
- 5. Patients Must have completed 3 or 4 previous chemotherapy regimens.
- 6. Patients must have measurable disease according to RECIST (v.1.1).
- 7. Patients must have an Eastern Cooperative Oncology Group(ECOG) performance status of 0 or1
- 8. Patients must have adequate organ function, defined as follows: a. Absolute neutrophil count≥1500/ul b. Platelets ≥150000/ul c. Hemoglobin≥10g/dL d. Serum creatinine≤1.5X upper limit of normal (ULN)or calculated creatinine clearance≥60ml/min using the Cockcroft-Gault equation e. Total bilirubin≤1.5X ULN OR direct bilirubin≤1X ULN f. Aspartate aminotransferase and alanine aminotransferase≤2.5X ULN unless liver metastases are present, in which case they must be ≤5X ULN
- 9. Patients must be either postmenopausal, free from menses for>12 months, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from heterosexual activity throughout the study, starting with enrollment through 90 days after the last dose of study treatment
- 10. Patients must have formalin-fixed, paraffin-embedded tumor samples available form primary or recurrent cancer.
- 11. Patients must be able to take oral medications and capable of complying with treatment and follow up visit
Exclusion Criteria:
- 1. Patients who have received other investigational drugs within 4 weeks or 5X t1/2 before first dose of study treatment.
- 2. Patients have had palliative radiotherapy encompassing>20% of the bone marrow within 3 weeks of the first dose of study treatment.
- 3. Patients have any known, persistent(>4 weeks),≥Grade 3 anemia, neutrophil count decrease or platelet count decrease during the last chemotherapy.
- 4. Patients have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last chemotherapy.
- 5. Patients have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
- 6. Patients have symptomatic uncontrolled brain or leptomeningeal metastases. The patient have new or progressive signs or symptoms related to the CNS disease and not taking a stable dose of steroids or no steroids. A scan to confirm the absence of brain metastases is not required.
- 7. Patients have known hypersensitivity to the components of niraparib
- 8. Patient have had major surgery within 3 weeks of fist dose treatment and patient must have recovered form any effects of any major surgery
- 9. Patients have had diagnosis, detection, or treatment of invasive cancer other than ovarian cancer ≤2 years prior to enrollment(except basal or squamous cell carcinoma of the skin that has been definitively treated)
- 10. Patients are considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to: 1. uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction 2. uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome or any psychiatric disorder that prohibits obtaining informed consent 3. immune deficiency (not including splenectomy) 4. HIV infection or active hepatitis(i.e. hepatitis B with HBV-DNA>500IU/ml or hepatitis C with positive HCV-RNA).
- 11. Patients have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
- 12. Patients have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- 13. Patients have current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ZL-2306(Niraparib)
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate(ORR)
Time Frame: Up to 3 years
|
The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1).
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response (DoR)
Time Frame: Up to 3 years
|
DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1).
|
Up to 3 years
|
Disease Control Rate (DCR)
Time Frame: Up to 3 years
|
Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1).
The exact method was used to calculate 95% confidence interval.
|
Up to 3 years
|
Progression Free Survival (PFS)
Time Frame: Up to 3 years
|
Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1).
|
Up to 3 years
|
Overall Survival (OS)
Time Frame: Up to 3 years
|
Overall Survival was defined as the time from the date of the first dose to the date of death by any cause.
|
Up to 3 years
|
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE To evaluate the safety and tolerability of niraparib
Time Frame: Up to 3 years
|
An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment.
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rutie Yin, West China Second University Hospital
- Principal Investigator: Hong Zheng, Peking University Cancer Hospital & Institute
- Principal Investigator: Ge Lou, Harbin Medical University
- Principal Investigator: Hongmin Pan, Sir Run Shaw Hospital, school of medicine, Zhejiang University
- Principal Investigator: Zhongqiu Lin, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 4, 2020
Primary Completion (ACTUAL)
April 8, 2021
Study Completion (ACTUAL)
August 11, 2022
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
May 15, 2020
First Posted (ACTUAL)
May 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Poly(ADP-ribose) Polymerase Inhibitors
- Niraparib
Other Study ID Numbers
- ZL-2306-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
Clinical Trials on ZL-2306(Niraparib)
-
Zai Lab (Shanghai) Co., Ltd.Completed
-
Zai Lab (Shanghai) Co., Ltd.Active, not recruitingPlatinum-sensitive Relapsed Ovarian CancerChina
-
Zai Lab (Shanghai) Co., Ltd.TerminatedExtensive-stage Small Cell Lung CancerChina
-
Zai Lab (Shanghai) Co., Ltd.Active, not recruiting
-
Chengdu Zenitar Biomedical Technology Co., LtdRecruitingRheumatoid Arthritis (RA) | Inflammatory Bowel Disease - IBD1China
-
Zai Lab Pty. Ltd.UnknownChronic Obstructive Pulmonary Disease | Asthma | Idiopathic Pulmonary FibrosisAustralia
-
Zai Lab (Shanghai) Co., Ltd.Zai Lab (US) LLCRecruiting
-
Zai Lab (Hong Kong), Ltd.Zai Lab (US) LLCNot yet recruitingPlaque PsoriasisAustralia, Canada
-
Zai Biopharmaceutical (Suzhou) Co., Ltd.Recruiting
-
Zai Lab (Shanghai) Co., Ltd.Completed