Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer
NCT ID: NCT04556071
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
32 participants
INTERVENTIONAL
2020-11-06
2022-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Niraparib-bevacizumab combination
Niraparib-bevacizumab combination therapy until disease progression
Niraparib
Niraparib will be administered orally once a day continuously throughout each 21-days cycle. The initial dose will be based on the participant's basal body weight or platelet count. Participants with basal body weight≥77 kg and basal platelet count of≥150,000/microliter (μL) will take 300 mg daily. While participants with basal body weight\<77 kg and/or basal platelet count \<150,000/μL will take 200 mg daily.
Bevacizumab
The dose of Bevacizumab will be 15 mg/kg that administered via a 30-minute intravenous infusion on day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Niraparib
Niraparib will be administered orally once a day continuously throughout each 21-days cycle. The initial dose will be based on the participant's basal body weight or platelet count. Participants with basal body weight≥77 kg and basal platelet count of≥150,000/microliter (μL) will take 300 mg daily. While participants with basal body weight\<77 kg and/or basal platelet count \<150,000/μL will take 200 mg daily.
Bevacizumab
The dose of Bevacizumab will be 15 mg/kg that administered via a 30-minute intravenous infusion on day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participant must be female ≥18 years of age;
3. Histologically confirmed FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
4. Participants must have high-grade serous or endometrioid histology;
5. Subjects were initially treated with platinum, and the disease recurrence occurred within 6 months after the end of the previous platinum-containing chemotherapy, that is, platinum resistance relapsed; Subjects have disease progression during initial platinum based chemotherapy defined as platinum refractory;
6. Patients may have received a PARP inhibitor as first-line maintenance therapy;
7. Patients may have received bevacizumab though no other prior use of anti-angiogenic therapy；
8. Subjects must have measurable lesions (according to RECIST1.1) and radiologically confirmed disease progression at the time of previous treatment; or CA125 elevated for two consecutive times and 2.5 times upper the limit of normal value；
9. Subject agrees to take blood samples for gBRCA mutations, can provide formalin-fixed, paraffin-embedded tumor tissue samples for sBRCA and homologous recombination deficiency(HRD) detection;
10. Life expectancy\>12 weeks;
11. Subject's ECOG physical status score is 0-2;
12. Good organ function, including:Neutrophil count≥1500/μL;Platelets≥100,000/μL;Hemoglobin≥10g/dL;Serum creatinine≤1.5 times the upper limit of normal value, or creatinine clearance≥60mL/min (calculated according to Cockcroft-Gault formula);Total bilirubin≤1.5 times the upper limit of normal value or direct bilirubin≤ 1.0 times the upper limit of normal value;AST and ALT≤2.5 times the upper limit of normal value. When liver metastases are present, it must be≤5 times the upper limit of normal value;
13. For women with fertility potential, if blood test or urine pregnancy test is negative within one week before enrollment, effective contraceptive measures must be taken, such as physical barrier contraceptive method (condom) or complete abstinence. Oral, injectable or implantable hormonal contraceptives are not allowed. Or women without reproductive potential, defined as: I. Natural menopause and menopause for more than 1 year; II. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); III. serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels were within the menopausal criteria of the research center laboratory;
14. Subject is able to adhere to the protocol;
15. The adverse effect of any previous chemotherapy have recovered to ≤ Grade1 (CTCAE v5.0) or baseline levels, except for sensory neuropathy or hair loss with stable symptoms ≤ Grade2 (CTCAE v5.0).
Exclusion Criteria
2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
3. People who are known to be allergic to Niraparib or Bevacizumab (or active or inactive ingredients of drugs with similar chemical structure);
4. People who are inability to swallow oral drugs and any gastrointestinal diseases that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption;
5. Major surgery was performed within 4 weeks before the start of the study or did not recover after the operation;
6. Received palliative radiotherapy of \>20% bone marrow 1 week before enrollment;
7. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
8. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
9. Patients with serious and uncontrollable diseases or the general situation of the subjects judged by the researchers to be unsuitable for enrolling the study, including but not limited to: active viral infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; severe cardiovascular disease, uncontrollable ventricular arrhythmia, myocardial infarction in the last three months; uncontrollable grand mal epilepsy, Unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect patients to sign the informed consent; hypertension beyond drug control; immune deficiency (except splenectomy) or other diseases that researchers consider may expose patients to high-risk toxicity;
10. The previous history of thromboembolism was defined as: uncontrolled pulmonary embolism, deep venous thrombosis, and other related conditions after anticoagulant therapy for more than 3 months before enrollment;
11. Any medical history or existing clinical evidence indicates that there may be confusion of study results, interference with patients' compliance with the trial protocol throughout the study treatment period, or not in the best interests of patients;
12. Receive platelet or red blood cell transfusions within 4 weeks;
13. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiaoxiang Chen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaoxiang Chen
Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaoxiang Chen, MD,PhD
Role: STUDY_CHAIR
Jiangsu Cancer Institute & Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
JiangSu Cancer Hospital
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xiaoxiang Chen, PhD
Role: primary
Jing Ni, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JiangsuCH001
Identifier Type: -
Identifier Source: org_study_id