EUCTR2006-002045-36-FR进行中（未招募）1 期
Phase II Study of Dasatinib (BMS-354825) for Advanced ‘Triple-negative’ Breast Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 16-Aug-06)+ Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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) Signed written informed consent according to institutional guidelines.
- •Target population
- •2) Invasive breast cancer based on previous biopsy, documented as negative for expression of Estrogen and Progesterone Receptor [<10% of cells stained] and for Her2/neu [IHC 0-1+ or CISH/FISH-negative]
- •3) A paraffin-embedded tissue block from prior surgery must be available
- •4) Measurable, recurrent or progressive, locally-advanced or metastatic disease assessed within 28 days prior to study drug start (see Protocol section 3.2). At least one target lesion (see Protocol section 3.3.2) must be identified.
- •5) Prior chemotherapy with an anthracycline, a taxane, or both (adjuvant or metastatic)
- •6) Zero or one chemotherapy regimen in the locally-advanced or metastatic setting
- •7) Recovered to Grade =1 from toxicities of prior therapy (except alopecia)
- •8) Performance status (ECOG) 0 – 1
- •9) Adequate organ function (CTCAE v.3.0 severity grading):
- •a) Hepatic enzymes (AST, ALT), Total bilirubin all Grade 0 – 1
- •b) Serum Ca2+ = Lower Limit of Normal (LLN)
- •c) Serum K+, Mg2+, Phosphate all Grade 0 – 1
- •d) Creatinine Grade 0 – 2
- •e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0 – 1
- •Age and Sex
- •10) Females, age = 18 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Sex and Reproductive Status
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study.
- •2) Women who are pregnant or breastfeeding
- •3) Women with a positive pregnancy test on enrollment or prior to study drug administration
- •Target Disease Exceptions
- •4) Metastatic disease confined to bone only
- •5) Symptomatic CNS metastasis (see section 7.2.1)
- •Medical History and Concurrent Diseases
- •6) Any anti-neoplastic therapy, including radiotherapy, or intravenous bisphosphonate within 14 days prior to study drug start
- •7) Prior administration of any small-molecule ‘targeted’ kinase inhibitor or any investigational agent
- •8) Other malignancy requiring radiotherapy or systemic treatment within 3 years
- •9) Concurrent medical condition which may increase the risk of toxicity, including:
- •a) Pleural or pericardial effusion of any grade
- •b) Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand’s disease)
- •c) Infection requiring intravenous antibiotics
- •d) Requirement for prohibited concomitant therapy (see section 6.4.1)
- •e) Ongoing or recent (=3 months) significant gastrointestinal bleeding
- •f) Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc >450 msec. (Fridericia correction), EF <40% or major conduction abnormality (unless a cardiac pacemaker is present)
- •g) Other medical condition which in the opinion of the Investigator might confer an unacceptable increase in risk
- •Other Exclusion Criteria
- •10) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- •11) Inability to take oral medication for any reason
- •12) Inability to understand the potential risks and provide informed consent
研究者
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