EUCTR2006-003742-42-IT进行中（未招募）不适用
A dose finding phase II study of Alimta in i.v. continuous infusion in patients with malignant pleural mesothelioma, non small cell lung cancer, pancreatic cancer and breast cancer - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- All
入选标准
- •1.Patients must have histologically or cytologically confirmed of MPM, NSCLC, Metastatic Breast cancer, Pancreatic cancer in advanced stage, not surgically treatable and /or relapsed after conventional chemotherapy.
- •2.Patients may have preferably evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease. Patients with evaluable disease may be enrolled in this dose-finding study provided that they are evaluable for toxicity.
- •3.Patients may be pretreated with chemo and/or previous radiotherapy. At least 1 month has to be passed from the end of previous treatment
- •4.Age >18 years.
- •5.Life expectancy of greater than 3 months .
- •6.ECOG performance status <2
- •7.Patients must have normal organ and marrow function as defined below:
- •-leukocytes>3,000/mL
- •-absolute neutrophil count >1,500/mL
- •-platelets>100,000/mL
- •-total bilirubin within normal institutional limits
- •-AST(SGOT)/ALT(SGPT)<2.5 X institutional upper limit of normal
- •-creatinine clearance>60 mL/min
- •8.The effects of Alimta on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Alimta is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •9.Ability to understand and the willingness to sign a written informed consent document.
- •10.Negative pregnancy test with 7 days from study entry.
- •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
- •1.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •2.Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Alimta or other agents used in the study
研究者
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