EUCTR2009-017101-11-AT进行中（未招募）不适用
A Pilot Study of Erlotinib and Temsirolimus in Patients with Advanced Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment
MUW, Klinik für Innere Medizin I, Onkologie0 个研究点目标入组 20 人开始时间: 2010年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Histologically or cytologically confirmed stage IIIB or IV NSCLC.
- •Measurable disease according to RECIST Criteria 1.1 11
- •Relapsed or progressed after treatment with 1 or 2 (no more than 2) prior chemotherapy regimens (with or without bevacizumab), at least 1 of which must have been a platinum-based treatment. Patients may not have received investigational therapy as their only prior therapy.
- •Recovered from the toxic effects of prior therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- •At least 18 years of age.
- •Adequate hematologic function as defined by: white blood cell (WBC) count = 2500 cells/µL; absolute neutrophil count (ANC) = 1500 cells/µL; platelet count = 100,000/µL; adequate hepatic, and renal function within 7 days prior to randomisation as defined by serum creatinine < 1.5 x the upper limit of normal (ULN) 1; total bilirubin < 1.5 x ULN; AST and ALT < 3 x ULN (if clearly attributable to liver metastases, = 5 x ULN is permitted).
- •Fasting serum cholesterol < 2.0 x ULN (therapy permitted), fasting serum triglycerides < 2.0 x ULN (therapy permitted), fasting glycosolated hemoglobin A1c (HbA1c) < 9 % (therapy permitted)
- •Women of childbearing potential must be practicing a medically acceptable contraceptive regimen and must have a negative serum pregnancy test within 14 days prior to inclusion. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test.
- •Men who are not surgically sterile must be practicing a medically safe and effective contraceptive regimen from the time of study inclusion, and agree to continue practicing until at least 90 days after the last administration of study treatment.
- •Accessible for repeat dosing and follow-up.
- •Life expectancy of greater than 12 weeks.
- •Given written informed consent (IC).
- •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
- •Active concurrent primary malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for at least 5 years.
- •Use of any investigational drugs, biologics, or devices within 4 weeks prior to inclusion.
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to inclusion.
- •Previous exposure to temsirolimus or erlotinib (or other TKIs).
- •Women who are pregnant or breastfeeding.
- •Not recovered from uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- •Uncontrolled hypertension.
- •Known HIV-positive status.
- •Treatment with vitamin K antagonists
- •Active smokers (currently smoking more than one cigarette per day for at least one year)*
- •Concomitant treatment with strong CYP3A4 inhibitors or inducers
- •Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required.
- •Patients with known hypersensitivity reactions to Torisel® or Tarceva®
- •Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin and azithromycin)
- •* as smoking is known to reduce exposure to erlotinib.
研究者
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