EUCTR2015-002057-35-HU进行中（未招募）1 期
A Phase 1-2 ascending dose study to assess the pharmacodynamics, pharmacokinetics, and safety of HSP 130 in subjects with non metastatic breast cancer following single dose and multiple dose administration by subcutaneous injection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics Committee (IEC) prior to any study related activities
- •2. Females = 18 years
- •3. Histologically confirmed and documented invasive breast cancer
- •4. Breast cancer without evidence of distant metastases (non-Stage 4) based on staging work-up
- •5. Chemotherapy naïve, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide based regimen, i.e., TAC as background chemotherapy
- •6. Zubrod/WHO/ECOG performance status = 2
- •7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:
- •a. Hemoglobin = 10 mg/dL
- •b. ANC = 1.5 x 109/L
- •c. Platelet count of = 100 x 109/L
- •d. Total bilirubin = 2 mg/dL
- •e. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 3 x the upper limit of normal (ULN) of the reference lab
- •f. Serum creatinine of = 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of = 60 mg/min
- •8. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status.
- •9. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Previous granulocyte colony stimulating factor (G CSF) exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM CSF), or any other branded or biosimilar G CSF
- •2. Prior autologous stem cell harvest of any type
- •3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to Escherichia coli (E. coli) derived proteins, filgrastim, other G CSFs, or pegylated agents
- •4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin
- •5. Chemotherapy other than that included in this study (i.e., taxane/cyclophosphamide-based regimen, i.e., TAC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP 130, prior bone marrow or stem cell transplantation, or malignancy within 5 years
- •6. Known HER2+ (overexpressing breast cancer)
- •7. Known triple negative (estrogen receptor negative, progesterone receptor negative and HER2 negative) breast cancer
- •8. Medical conditions including but not limited to: Known sickle cell disease; known severe persistent drug induced myelosuppression; severe uncontrolled cardiac disease; any malignancy other than breast with the exception of adequately treated squamous or basal cell carcinoma or the skin or cervical carcinoma in situ within 5 years; pregnancy or lactation; received live, live attenuated, or non live vaccine within 4 weeks
- •9. Current or recent treatment (within 30 days before the first administration of the HSP 130) with any other Investigational Medicinal Product
- •10. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP 130, or patient is high risk for treatment complication
研究者
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