NCT00042315终止3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- QLT Inc.
- 入组人数
- 490
研究概览
简要总结
To determine whether tariquidar + first-line single agent vinorelbine chemotherapy in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly improve overall survival compared with placebo + vinorelbine. To compare the effects of tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with Stage IIIb/IV NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
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
- •Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage IV, requiring first-line chemotherapy.
- •Patients who have a WHO performance status of 2 and life expectancy of greater than 3 months.
- •Patients who are 18 years of age or older and age of consent.
- •Patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control.
- •Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine equal or less than 141 µmol/L (1.6 mg/dL) or calculated creatinine clearance less or equal to 60 mL/min prior to study treatment.
- •Patients who are able to give written informed consent and comply with the protocol.
排除标准
- •Patients who are eligible for radiotherapy or surgery for curative intent.
- •Patients who have had previous chemotherapy for NSCLC.
- •Patients who have a WHO performance status less than 2 or greater than
- •Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from WHO histological typing of lung tumors [66]).
- •Patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma.
- •Patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections.
- •Patients who have symptomatic brain metastases.
- •Patients who have other medical or surgical conditions that would contraindicate chemotherapy.
- •Patients who have received experimental therapies within the last 4 weeks.
- •Patients who have know hypervitaminosis or known sensitivity to ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin E.
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