NCT04811443Unknown不适用
DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- Biocad
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Relative dose-intensity (RDI) of the myelosupressive therapy course
研究概览
简要总结
This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form;
- •Histologically verified diagnosis;
- •Age between 18 and 80 years;
- •If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug;
- •ECOG performance 0-2;
- •Haematology:
- •ANC ≥ 1,5 х 10(9) /L;
- •Platelets ≥ 100 х 10(9) /L;
- •Hemoglobin ≥ 90 g/L;
- •Biochemistry:
- •Creatinine ≤ 1,5 ULN;
- •Total bilirubin ≤ 1,5 ULN;
- •AST/ALT ≤ 2,5 ULN;
- •Alkaline phosphatase ≤ 5 ULN;
- •Life expectancy of at least 6 months from the date of the first drug administration in the study;
- •Ability of the patient to comply with the Protocol requirements.
排除标准
- •Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs;
- •Systemic use of antibiotics less than 72 hours before the first drug administration in the study;
- •Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study;
- •Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study;
- •Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study;
- •History of bone marrow or hematopoietic stem cell transplantation;
- •Presence of acute or active chronic infections;
- •Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods;
- •Inability to administer the drug by intravenous infusion or subcutaneous injection.
研究组 & 干预措施
Patients with solid tumors who have received myelosupressive therapy
干预措施: Empegfilgrastim (Drug)
结局指标
主要结局
Relative dose-intensity (RDI) of the myelosupressive therapy course
时间窗: 12 months
次要结局
- Grade 3-4 adverse events frequency(18 months)
- Serious adverse events frequency(18 months)
- Frequency of study withdrawal due to adverse events(18 months)
- Any grade adverse events frequency(18 months)
- The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control(18 months)
- The incidence of neutropenia leading to a dose reduction of cytostatic drugs and / or an increase of the interval between cycles when using empegfilgrastim supportive therapy compared with historical controls(18 months)
- RDI of chemotherapy courses performed in relation to nosology(18 months)
- The incidence of severe infections (grade 3-4)(18 months)
- Frequency of antibiotic prescription(18 months)
- RDI of chemotherapy courses performed in relation to treatment regimen(18 months)
研究者
研究点 (3)
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