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

NCT ID: NCT03774680

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-01-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer Colo-rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cetuximab nanoparticles goup

A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles

Group Type ACTIVE_COMPARATOR

Cetuximab nanoparticles

Intervention Type DRUG

The active group will receive cetuximab in nanoparticles as an anti-microbial drug.

Oral approved anticancer drug

A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.

Group Type PLACEBO_COMPARATOR

Oral approved anticancer drug

Intervention Type DRUG

The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cetuximab nanoparticles

The active group will receive cetuximab in nanoparticles as an anti-microbial drug.

Intervention Type DRUG

Oral approved anticancer drug

The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral capsules oral capsules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ahmed A. H. Abdellatif

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed A. H. Abdellatif

Assistant Professor of Pharmaceutics, Faculty of Pharmacy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut Clinic

Asyut, , Egypt

Site Status RECRUITING

Buraidah Clinic

Buraidah, Al Qassim, Saudi Arabia

Site Status RECRUITING

Faculty of Pharmacy

Buraidah, Al-Qassim Region, Saudi Arabia

Site Status RECRUITING

Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Buraidah, Al-Qassim Region, Saudi Arabia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt Saudi Arabia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed AH Abdellatif, PhD

Role: CONTACT

+966507726856 ext. 14618

Ahmed AH Abdellatif, PhD

Role: CONTACT

+966507726856 ext. 2014

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed AH Abdellatif, PhD

Role: primary

+966507726856

Ahmed AH Abdellatif, Ph.D.

Role: primary

+966507726856

Ahmed AH Abdellatif, Ph.D.

Role: primary

+966507726856

Ahmed AH Abdellatif, Ph.D.

Role: primary

+966507726856

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 29881409 (View on PubMed)

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: 10.3109/03639045.2016.1173052. Epub 2016 May 5.

Reference Type RESULT
PMID: 27032509 (View on PubMed)

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, Coleman MP; CONCORD Working Group. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25,676,887 patients from 279 population-based registries in 67 countries (CONCORD-2). Lancet. 2015 Mar 14;385(9972):977-1010. doi: 10.1016/S0140-6736(14)62038-9. Epub 2014 Nov 26.

Reference Type RESULT
PMID: 25467588 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AlAzharCetuximab

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Proton Therapy in Reducing Toxicity in Anal Cancer
NCT03018418 ACTIVE_NOT_RECRUITING PHASE2