Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer

Colon Cancer Clinical Trial

Official title:

Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774680
• Other study ID #: AlAzharCetuximab
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: October 2019
• Source: Al-Azhar University
• Contact: Ahmed AH Abdellatif, PhD
• Phone: +966507726856
• Email: a.abdellatif[@]qu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 11, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Peptic ulcer

• Stomach disease

• Colon cancer

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colon Cancer
• Colonic Neoplasms
• Colorectal Neoplasms

Intervention

Drug:
• Cetuximab nanoparticles
The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
• Oral approved anticancer drug
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.

Locations

Country	Name	City	State
Egypt	Assiut Clinic	Assiut
Saudi Arabia	Buraidah Clinic	Buraidah	Al Qassim
Saudi Arabia	Faculty of Pharmacy	Buraidah	Qassim
Saudi Arabia	Pharmaceutics dept., Faculty of Pharmacy, Qassim University	Buraidah	Qassim

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed A. H. Abdellatif

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

References & Publications (3)

Abdellatif AA, Zayed G, El-Bakry A, Zaky A, Saleem IY, Tawfeek HM. Novel gold nanoparticles coated with somatostatin as a potential delivery system for targeting somatostatin receptors. Drug Dev Ind Pharm. 2016 Nov;42(11):1782-91. doi: 10.3109/03639045.20 — View Citation

Allemani C, Weir HK, Carreira H, Harewood R, Spika D, Wang XS, Bannon F, Ahn JV, Johnson CJ, Bonaventure A, Marcos-Gragera R, Stiller C, Azevedo e Silva G, Chen WQ, Ogunbiyi OJ, Rachet B, Soeberg MJ, You H, Matsuda T, Bielska-Lasota M, Storm H, Tucker TC, — View Citation

Hafez Abdellatif AA, Abdelhafez WA, Sarhan HA. Somatostatin Decorated Quantum Dots for Targeting of Somatostatin Receptors. Iran J Pharm Res. 2018 Spring;17(2):513-524. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer	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.	one year