EUCTR2006-001990-32-IT进行中（未招募）不适用
A Randomized, Open-Label, Phase 3 Trial of NOV-002 in Combination withPaclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for theTreatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) - ND
OVELOS THERAPEUTICS INC.0 个研究点目标入组 840 人开始时间: 2007年5月24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
- 840
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 age >= 18 years of age, with histologically or cytologically
- •confirmed Stage IIIb with malignant pleural or pericardial effusion or
- •Stage IV (AJCC) NSCLC. Patients may have received prior treatment for
- •NSCLC as described in the inclusion/exclusion criteria.
- •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
- •(1) Prior chemotherapy for advanced NSCLC or the patient has received prior
- •neoadjuvant or adjuvant chemotherapy for NSCLC in the year prior to the
- •date of randomization
- •(2) Patients with CNS metastases
- •(3) Any systemic disease precluding chemotherapy
- •(4) Chronic use of systemic corticosteroids in pharmacological doses
- •(5) Known or history of HIV, HBV or HCV
- •(6) Palliative radiation therapy within 3 weeks prior to randomization
- •(7) Major surgery within 3 weeks prior to randomization
- •(8) Myocardial infarction within the 3 months prior to randomization
- •(9) Peripheral neuropathy > grade 2
- •(10) Patients that have had a splenectomy
- •(11) Contraindication to treatment with paclitaxel or carboplatin or any of the
- •components of NOV-002
- •(12) Any known preexisting medical condition, including substance abuse, that
- •could interfere with the patient's participation in and completion of the
- •(13) Have received any investigational drug, defined as a drug for which there is
- •no FDA approved indication, within the 30 days prior to randomization
- •(14) Pregnant female or nursing mother
研究者
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