NCT06081595尚未招募2 期
Fluzoparib Combined With Apatinib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Phase II Single-arm, Open Label, Multicenter Trial
Jin Li0 个研究点目标入组 54 人开始时间: 2023年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
This study is a Phase II single-arm, open label, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient voluntarily joined the study and signed the informed consent.
- •Age 18-75 years old.
- •Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma.
- •Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months.
- •Patients who have received previous treatment with bevacizumab are acceptable.
- •Allow previous treatment with PARP inhibitors other than Fluzoparib.
- •ECOG score: 0-
- •Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN
- •Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during he study treatment period and within 2 months after the last administration of apatinib or 6 months after the last administration of fluzopril, whichever is longer; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.
排除标准
- •Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery.
- •The subject has untreated central nervous system metastasis.
- •Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers.
- •Recent (within 3 months) occurrence of intestinal obstruction.
- •Patients with clinical symptoms of cancerous ascites and pleural effusion, who need puncture or drainage, or who have received ascites and pleural effusion drainage within 2 months before the first trial medication.
- •Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>470ms.
- •Those with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial.
- •The subject has an active infection or unexplained fever >38.5 degrees during the screening period and before the first dose;
- •Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal).
- •Those who had previously received radiotherapy, chemotherapy, endocrine therapy, or molecular targeted therapy and were enrolled less than 4 weeks after the completion of treatment (last dose); Adverse events (except alopecia) caused by previous treatment did not recover to ≤1 degree (CTCAE 5.0).
- •Patients who have used other drugs in clinical trial studies within the previous 4 weeks.
- •Subjects may receive other systemic anti-tumor therapies during the study period.
- •known allergy to Fluzoparib, apatinib and its excipients.
- •In the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subjects, or the collection of data and samples.
研究组 & 干预措施
Fluzoparib+Apatinib combination
Experimental
干预措施: Fluzoparib (Drug)
Fluzoparib+Apatinib combination
Experimental
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: Up to 2 years
To determine the efficacy by progression free survival (PFS) of the maintenance treatment in previous PARP inhibitor treated platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined).
次要结局
- Disease Control Rate (DCR）(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Overall survival (OS）(Up to 2 years)
- Adverse Events (AEs)(From the first drug administration to within 30 days for the last treatment dose)
研究者
Jin Li
MD
Fudan University
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