EUCTR2010-024481-22-HU进行中（未招募）1 期
A randomized, double-blind, parallel-group, multi-center Phase III studycomparing the efficacy and safety of EP2006 and Neupogen® in breastcancer patients treated with myelosuppressive chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Sandoz GmbH
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
- •1. Written informed consent before any assessment is performed
- •2. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy
- •3. Women = 18 years of age
- •4. Estimated life expectancy of more than six months
- •5. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •6. Adequate bone marrow function on Cycle 1 Day 1, prior to chemotherapy administration:
- •ANC = 1.5 x 109/L
- •Platelet count = 100 x 109/L
- •Hemoglobin = 10 g/dL
- •7. Total bilirubin within normal limits, unless the patient has Gilbert’s syndrome
- •8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level = 2 x upper limit of normal (ULN)
- •9. Liver-derived alkaline phosphatase level = 3 x ULN
- •10. Creatinine = 1.5 x ULN
- •11. For all women of childbearing potential: negative serum pregnancy test within seven days prior to randomization, and using a highly effective method of birth control.
- •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 163
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1.History of myelogenous leukemia or myelodysplastic syndrome
- •2. History or presence of sickle cell disease
- •3. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
- •4. Any serious illness or medical condition, that may interfere with safety, compliance, response to the products under investigation or chemotherapy and their evaluation, such as:
- •Active uncontrolled infection
- •Clinically significant impairment of left ventricular ejection fraction (LVEF) (measured within three month before study entry by echocardiography or Multiple Gated Acquisition scan (MUGA) must be above the lower limit of normal for the respective center)
- •Severe valvular heart disease, myocardial infarction, unstable angina pectoris, uncontrolled hypertension or uncontrolled arrhythmias within six months from study entry
- •Significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
- •5. Concurrent or prior radiotherapy within four weeks of randomization
- •6. Concurrent or prior chemotherapy for breast cancer
- •7. Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
- •8. Concurrent prophylactic antibiotics
- •9. Prior bone marrow or stem cell transplant
- •10. Previous therapy with any rhG-CSF product
- •11. Known hypersensitivity to E. coli proteins or any of the excipients used in the IMPs
- •12. Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening
- •13. Known control drug addiction, including alcoholism
- •14. Participation in any other clinical study using an IMP or device within three months before the screening visit
研究者
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3 期
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