EUCTR2010-023478-38-GB进行中（未招募）1 期
Open-label, Phase 2 Study of Single-agent Erlotinib for Patients with Pediatric Ependymoma Previously Treated with Oral Etoposide in Protocol OSI-774-205 - Erlotinib in paediatric ependymoma patients previously treated with etoposide
OSI Pharmaceuticals LLC0 个研究点目标入组 4 人开始时间: 2011年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
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
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed (according to study criteria) while on study or discontinued due to unacceptable toxicity related to etoposide;
- •Performance status: Lansky greater than or equal to 50% for patients not more than (NMT) 10 years of age or Karnofsky greater than or equal to 50% for patients > 10 years of age;
- •Patients must have recovered from any acute toxicity to any prior anti-cancer treatment;
- •Total bilirubinNMT 1.5 x upper limit of normal for age, SGPT (ALT) NMT 3 x ULN;
- •Serum creatinine based on age OR Creatinine Clearance/GFR greater than or equal to 70 mL/min/m2;
- •Age (Years)Serum Creatinine (mg/dL)
- •Less than 5 NMT 0.8
- •5 < age NMT 10 NMT 1.0
- •10 < age NMT 15 NMT 1.2
- •> 15 NMT 1.5
- •Patients must be neurologically stable for at least 7 days before registration;
- •Patients – both males and females – with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy; and
- •Patients must be able to swallow whole or crushed tablets.
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following exclusion criteria are not eligible for this study:
- •Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers = 14 days before registration;
- •Have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from OSI-774-205;
- •Taking proton pump inhibitors = 14 days before registration;
- •Participating in another investigational drug trial while on study; and/or
- •Pregnant or breast-feeding.
研究者
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