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

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ClinicalTrials.gov Identifier: NCT03774680
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed A. H. Abdellatif, Al-Azhar University

Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Colo-rectal Cancer Drug: Cetuximab nanoparticles Drug: Oral approved anticancer drug Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cetuximab nanoparticles goup
A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles
Drug: Cetuximab nanoparticles
The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
Other Name: oral capsules

Placebo Comparator: Oral approved anticancer drug
A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.
Drug: Oral approved anticancer drug
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
Other Name: oral capsules




Primary Outcome Measures :
  1. Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer [ Time Frame: 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.




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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774680


Locations
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Egypt
Assiut Clinic Recruiting
Assiut, Egypt, 71526
Contact: Ahmed AH Abdellatif, PhD    +966507726856    a.abdellatif@qu.edu.sa   
Saudi Arabia
Buraidah Clinic Recruiting
Buraidah, Al Qassim, Saudi Arabia, 51171
Contact: Ahmed AH Abdellatif, Ph.D.    +966507726856    a.abdellatif@qu.edu.sa   
Faculty of Pharmacy Recruiting
Buraidah, Qassim, Saudi Arabia, 51452
Contact: Ahmed AH Abdellatif, Ph.D.    +966507726856    a.abdellatif@qu.edu.sa   
Pharmaceutics dept., Faculty of Pharmacy, Qassim University Recruiting
Buraidah, Qassim, Saudi Arabia, 51452
Contact: Ahmed AH Abdellatif, Ph.D.    +966507726856    a.abdellatif@qu.edu.sa   
Sponsors and Collaborators
Ahmed A. H. Abdellatif

Publications of Results:
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Responsible Party: Ahmed A. H. Abdellatif, Assistant Professor of Pharmaceutics, Faculty of Pharmacy, Al-Azhar University
ClinicalTrials.gov Identifier: NCT03774680     History of Changes
Other Study ID Numbers: AlAzharCetuximab
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Somatostatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs