EUCTR2006-001990-32-GB进行中（未招募）1 期
A Randomized, Open-Label, Phase 3 Trial of NOV-002 in Combination with Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
ovelos Therapeutics, Inc.0 个研究点目标入组 840 人开始时间: 2008年2月21日最近更新:
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
- 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
入选标准
- •(1) Age = 18 years
- •(2) Histologically or cytologically confirmed NSCLC
- •(3) Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (AJCC) NSCLC
- •(4) ECOG performance score of 0 or 1
- •(5) Adequate bone marrow, hepatic, and renal function as indicated by the following parameters:
- •ANC = 1,500/mm3
- •Platelets = 100,000/ mm3
- •AST and ALT = 2.5 x ULN, except in patients w/ documented liver metastases where it may be AST and ALT = 5.0 x ULN
- •Total bilirubin = 1.5 times below the ULN
- •Creatinine = 1.5 x ULN and
- •(6) NYHA score 1-2
- •(7) Life expectancy of at least 12 weeks
- •(8) Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during the trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years).
- •(9) The patient or patient’s legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments.
- •(10) The patient must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
- •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 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) Patient that have a splenectomy
- •(11) Contraindication to treatment with paclitaxel or carboplatin or any of the components of NOV-002
- •(12) Any known pre-existing medical condition, including substance abuse, that could interfere with the patient’s participation in and completion of the protocol
- •(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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