NCT00664170已完成1 期
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 13
- 主要终点
- Pharmacokinetic equivalence of ANX-514 and Taxotere
研究概览
简要总结
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Over 18 years old.
- •Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment.
- •ECOG performance status of 0-2 and Karnofsky Score of 100-70.
排除标准
- •Patients who have more effective therapy available than single agent docetaxel for the malignancy.
- •Pregnancy or lactation.
- •Intolerance to any antineoplastic agents belonging to the taxoid family.
- •Hypersensitivity to drugs formulated with polysorbate
- •Active infection.
- •Prior anticancer therapy within 30 days prior to the first day of study treatment.
- •Participation in another experimental drug study within 30 days prior to the first day of study treatment.
研究组 & 干预措施
1
Experimental
ANX-514
干预措施: ANX-514 (Drug)
2
Active Comparator
Taxotere
干预措施: docetaxel (Drug)
结局指标
主要结局
Pharmacokinetic equivalence of ANX-514 and Taxotere
次要结局
未报告次要终点
研究者
研究点 (13)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid CancerSolid TumorNCT01336582Samyang Biopharmaceuticals Corporation42
Unknown
2 期
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before SurgeryBreast CancerNCT00251329Cancer Research Network48
已完成
不适用
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung CancerLung CancerNCT00675597Memorial Sloan Kettering Cancer Center25
进行中（未招募）
2 期
TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA SignatureTriple Negative Breast CancerBreast CancerNCT02641847Fudan University503
进行中（未招募）
1 期
A phase I/II study of Docetaxel (Taxotere, TM), Cisplatinum and Capecitabine (Xeloda, TM) (TCX) in patients with advanced oesophago-gastric cancer. - TCXocally advanced or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction or stomach.MedDRA version: 8.1 Level: LLT Classification code 10055102 Term: Oesophageal cancer metastaticEUCTR2006-002389-21-GBorth Wales NHS Trust80