Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer
研究概览
简要总结
Due to the great toxicity of chemotherapeutic drugs to both the healthy and cancerous area, the efficient targeting could be of great benefit for a patient with advanced or metastatic tumors. Colorectal cells carry somatostatin receptors which make them a promising target for antitumor therapy since this would reduce side effects and increase drug delivery efficacy to the target site.
详细描述
The investigator's aim is to deliver polymeric nanoparticles loaded with anti-cancer drug Cetuximab and decorated with somatostatin analogue in the form of oral polymeric nanoparticles, which can release at only above pH 6.8 using ethylcellulose polymer. The polymeric nanoparticles were prepared using the solvent evaporation method, further will be characterized for its drug content, size, encapsulation efficiency and drug-loading using UV spectroscopy. Moreover, the ethylcellulose nanoparticles loaded Cetuximab will release the Cetuximab at pH above 6.8, while can hold the Cetuximab at pH 1.5 which protecting the stomach from the toxicity Cetuximab. Then, the nanoparticles will target the colorectal cancer cells using octreotide, the somatostatin receptor agonist which will lead it to SSTRs overexpressed in colorectal cancer cells. The strategy of deposition of ligand will depend on using the advantage of the positive charge surface of nanoparticles which can absorb the negative charges of the targeting ligands. Final outcomes: this project will present a novel formulation for the treatment of colorectal cancer which can be delivered safely to the patients in a high dose to the affected tumor cells with reduced side effects on the other healthy cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of colon cancer
- •Follow up and collect data for a local and systemic activity of cetuximab
- •The systemic oral capsule of cetuximab be also given to enhance the activity as an anti-cancer activities
排除标准
- •Peptic ulcer
- •Stomach disease
- •Colon cancer
研究组 & 干预措施
Cetuximab nanoparticles goup
A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles
干预措施: Cetuximab nanoparticles (Drug)
Oral approved anticancer drug
A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.
干预措施: Oral approved anticancer drug (Drug)
结局指标
主要结局
Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer
时间窗: one year
Determine the bioavailability of Cetuximab after oral and intravenous administration. by measuring the peak levels of Cetuximab after 0.5 to 1.5 hours following ingestion. Determine the therapeutic window for Cetuximab after and before formulation in nanoparticles. Determine the different Cetuximab doses, peak plasma levels of Cetuximab for each formula.
次要结局
未报告次要终点
研究者
Ahmed A. H. Abdellatif
Assistant Professor of Pharmaceutics, Faculty of Pharmacy
Al-Azhar University
