NCT00294736已完成1 期
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens
OSI Pharmaceuticals9 个研究点 分布在 2 个国家目标入组 57 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 9
- 主要终点
- To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
研究概览
简要总结
This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke.
Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.
In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC;
- •Must have received 1 or 2 prior chemotherapy regimens for advanced NSCLC and now have progressive disease;
- •Must have recovered from any treatment-related toxicities prior to registration, except for alopecia, grade 1 fatigue, or grade 1 neurotoxicity;
- •A current cigarette smoker (minimum of 10 cigarettes per day for >= 1 year and have a positive test for cotinine) despite advice and support to quit;
- •Age >= 18 years;
- •ECOG PS 0-1 and predicted life expectancy >= 12 weeks;
- •Previous surgery is permitted provided that wound healing has occurred prior to registration;
- •Adequate hematopoietic, hepatic and renal function defined as follows: ANC >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, bilirubin <= 1.5 x ULN, ALT <= 2.5 x ULN (or 5 x ULN in case of liver metastases), creatinine <= 1.5 x ULN;
- •No prior treatment with Tarceva or gefitinib (or other drug with significant activity against EGFR (eg, cetuximab and/or ZD6474));
- •Patients with reproductive potential must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test within 14 days prior to registration;
- •Accessible for repeat dosing and follow-up.
排除标准
- •Any concurrent anticancer cytostatic or cytotoxic chemotherapy;
- •Concomitant CYP3A4 or CYP1A2 inducers/inhibitors (or during 14 days prior to study) with the exception of tobacco;
- •Other active malignancies, unless disease-free and without cancer-specific therapy for at least the last 5 years. Basal or squamous cell skin cancers are not excluded;
- •Significant history of cardiac disease unless the disease is well-controlled;
- •Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study;
- •History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements; of the study or to provide informed consent.
- •Gastrointestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption;
- •Clinically significant ophthalmologic abnormalities;
- •Pregnant or breast-feeding females. Males or females not practicing effective birth control;
- •Symptomatic brain metastases which are not stable, require steroids, or that have required radiation within the last 28 days;
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug;
研究组 & 干预措施
Arm A
Experimental
Arm A (Tarceva MTD established in Part I)
干预措施: Tarceva (Drug)
Arm B
Experimental
Arm B (150 mg Tarceva daily).
干预措施: Tarceva (Drug)
结局指标
主要结局
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
时间窗: 2 years
次要结局
- To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg.(2 years)
研究者
研究点 (9)
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