EUCTR2006-003699-36-DE进行中（未招募）不适用
A Phase 2, Randomized, Double Blind, Placebo- Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Chemotherapy- Induced Thrombocytopenia in Subjects With Advanced Non- Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum
Amgen Inc.0 个研究点目标入组 95 人开始时间: 2007年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
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
- •Disease related:
- •Histologically or cytologically confirmed locally advanced or metastatic stage IIIB (not amenable to surgery or radiotherapy with a curable intent) or stage IV NSCLC who will be receiving Q21 day gemcitabine / carboplatin or gemcitabine / cisplatin
- •Life expectancy = 12 weeks at the time of screening
- •Thrombocytopenia as evidenced by a platelet count < 50 x 109/L during the qualifying cycle of chemotherapy, OR platelet count < 100 x 109/L on Day 22 of the qualifying cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on study), this criteria ensures that the subject must be dose delayed for platelet recovery
- •Ability to receive the same dose and schedule of chemotherapy during the first on study treatment cycle as was given in the qualifying cycle (except Day 8 gemcitabine)
- •ANC > 1,000/µL, Hgb > 9.5 g/dL, and platelet count > 100 x 109/L on Day 1 of the first on study chemotherapy treatment cycle
- •Demographic
- •Subject must be = 18 years of age
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance of 0 - 2 at the time of screening
- •Adequate liver function; AST and ALT < 3.0 x ULN (except for subjects with liver mets which will be excluded if > 5 x ULN); and serum bilirubin = 1.5 times ULN (except for subjects with a confirmed diagnosis of Gilbert’s Syndrome)
- •Adequate renal function; serum creatinine < 1.5 x ULN
- •Before any study-specific procedure, the appropriate written informed consent must be obtained
- •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
- •Disease Related
- •Receipt of >1 prior systemic chemotherapy regimen
- •Sepsis, disseminated intravascular coagulation, or any other condition (i.e. ITP, TTP,
- •HUS) that may have exacerbated thrombocytopenia
- •History of unstable angina, CHF {NYHA >class II, see Appendix F}, uncontrolled
- •hypertension {diastolic>100mmHG}, uncontrolled cardiac arrhythmia, or recent (within 1 year of screening) MI
- •History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
- •History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
- •Medications
- •Receipt of any nitrosourea (BCNU, CCNU) or mitomycin-C within 6 weeks of screening
- •Receipt of any thrombopoietic growth factor or related substance
- •Receipt of granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
- •Receipt of any experimental therapy within 4 weeks prior to screening
- •Receipt of a bone marrow or peripheral blood stem cell infusion (within 1 year of
- •Pregnant or breastfeeding
- •Reproductive potential and not using adequate contraceptive precautions in the
- •judgment of the investigator
- •Hypersensitivity to any recombinant E. Coli-derived product
- •Inability to comply with the protocol
研究者
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