EUCTR2015-003610-25-DE进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, parallel-design, multi-centre study to investigate the efficacy to reduce chemotherapy-induced neutropenia (CIN), effects on the haematopoietic system, safety and pharmacokinetics of Myelo001 in patients receiving adjuvant or neoadjuvant chemotherapy for the treatment of breast cancer - MyeloConcept
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Eligible patients must meet ALL of the following inclusion criteria:
- •1. Female patient of any racial origin having fulfilled her 18th birthday on Visit 1 (Screening)
- •2. Histologically confirmed invasive breast cancer scheduled for neoadjuvant CTX or adjuvant CTX (patient with primary wound healing ([R0])
- •3. Already selected for neoadjuvant or adjuvant standard of care poly-chemotherapy regimen containing anthracyclines in combination with cyclophosphamide (with or without follow-up treatment with taxanes) defined as EC standard regimen
- •4. Risk of CTX induced FN =20% according to ASCO guidelines (2015)
- •5. More than 5 days remaining before the planned initiation of the 1st CTX cycle (d1/c1) to allow initiation of IMP on d-5/c1
- •6. Performance status Grade 0-1 (ECOG)
- •7. Echocardiography: No contraindication for the scheduled CTX
- •8. Haematologic and chemistry thresholds at baseline:
- •Absolute neutrophil count (ANC) =2,000 cells/ mm3 (=2.0 x 10^9/L)
- •Platelet count =100,000/mm3 (=100 x 10^9/L)
- •Haemoglobin =10 g/dL
- •Total bilirubin <1.5 x, AST, ALT <2.5 x upper limit of normal (ULN)
- •Serum creatinine <2.0 mg/dL
- •9. Able to read, understand and willing to sign the informed consent form
- •10. Able to undergo the investigations and to follow the Visit schedule
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •A patient will be excluded from participation in the trial, if one or more of the following exclusion criteria are identified:
- •1. Suspected allergy to Myelo001 or its excipients
- •2. Prior chemotherapy
- •3. Prior or concomitant treatment with radiotherapy
- •4. Currently on or scheduled for other immunomodulatory or immunosuppressive therapies (e.g. TNF inhibitors) for the first CTX cycle
- •5. Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF) for the first CTX cycle
- •6. Currently on or scheduled for primary prophylaxis with antibiotics for the first CTX cycle
- •7. History of bone marrow transplantation or stem cell transplant
- •8. Administration of another IMP / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed
- •9. Already confirmed HIV, HBV or HCV infection
- •10. History of somatic disease/condition that may interfere with the
- •objectives of the study
- •11. Any other medical disease or clinical laboratory parameter outside the normal range and of clinical significance according to the investigator
- •12. Serious uncontrolled comorbidities
- •13. Pregnant or breast-feeding subject
- •14. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study
研究者
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