CTRI/2012/06/002736Other1 期
A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Docetaxel InjectionConcentrate for Nano-Dispersion (DICN) in Subjects With Unresectable LocallyAdvanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Safety and Efficacy (Objective response rate as per RECIST, 1.1)
研究概览
简要总结
This is an open label study to assess the safety, tolerability, pharmacokinetic, and efficacy of Docetaxel Injection Concentrate for Nano-Dispersion (DICN) in subjects with unresectable locally advanced or metastatic non small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Histologically or cytologically diagnosed unresectable locally advanced19 or metastatic NSCLC with taxane-based therapy a rational treatment option; 2.Must have been treated with at least one prior chemotherapy regimen or targeted EGFR inhibitor for locally advanced or metastatic NSCLC; 3.Male or female subjects with age 18 to 70 years, inclusive; 4.Performance status ≤ 2 on the ECOG performance scale; 5.Estimated life expectancy of at least 12-weeks; 6.Measurable or evaluable disease as per RECIST 1.1 criteria; 7.Adequate organ and immune system function as indicated by the following laboratory values, obtained ≤ 2 weeks prior to dosing: •Hematology:ANC ≥ 1.5 × 109/L, Hemoglobin ≥ 9.0 g/dL, Platelets ≥ 100 × 109/L •Renal:Serum creatinine ≤ 2.0 mg/dL •Hepatic:Total bilirubin ≤ upper limit of normal (ULN, Aspartate aminotransferase (AST) ≤ 1.5 × ULN, Alanine aminotransferase (ALT) ≤ 1.5 × ULN, Alkaline phosphatase ≤ 5 × ULN 8.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator (such as condoms, foams,jellies, diaphragm, intrauterine device, oral or long acting injected contraceptives) from at least 2 months prior to enrollment and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative serum pregnancy test; 9.Willing to participate and give written informed consent.
排除标准
- •1.Prior adjuvant chemotherapy or biological therapy for relapsed NSCLC if completed less than 1 year prior to first relapse of locally advanced19 or metastatic disease (prior surgery or radiotherapy allowed); 2.Prior docetaxel therapy for NSCLC; 3.Clinically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to enrollment; 4.Any other malignancy within 5 years with the exception of adequately treated basal or squamous cell skin cancer or adequately treated in situ carcinoma; 5.Known hypersensitivity to the study drugs or their excipients or analogs; 6.Treatment with any investigational agents within 30 days of enrollment; 7.Active and uncontrolled infection; 8.Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow-up; 9.Presence of clinically symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; 10.Pre-existing peripheral neuropathy (Grade 2 or higher – as per CTCAE); 11.Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for getting enrolled in the study; 12.Human immunodeficiency virus (HIV) positive or who have an Acquired Immune Deficiency Syndrome (AIDS)-related illness; 13.Prior radiation therapy to ≥ 25% of the bone marrow (e.g. whole pelvic radiation is allowed).
- •Subjects must have recovered from the acute side effects of radiotherapy; 14.Prior bone marrow/stem cell transplantation; 15.Known Hepatitis B or C, or history of chronic active Hepatitis B or C.
结局指标
主要结局
Safety and Efficacy (Objective response rate as per RECIST, 1.1)
时间窗: at the end of 6 cycles
次要结局
- Best overall response as per RECIST, 1.1(during study phase)
- Progression-free survival (PFS)(12 months and 18 months)
- Overall survival (OS)(after a minimum of two cycles of treatment)
研究者
研究点 (7)
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