Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer
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ClinicalTrials.gov Identifier: NCT03774680 |
Recruitment Status : Unknown
Verified October 2019 by Ahmed A. H. Abdellatif, Al-Azhar University.
Recruitment status was: Recruiting
First Posted : December 13, 2018
Last Update Posted : October 10, 2019
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer Colo-rectal Cancer | Drug: Cetuximab nanoparticles Drug: Oral approved anticancer drug | Phase 1 |
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, 2020 |
Estimated Primary Completion Date : | February 1, 2020 |
Estimated Study Completion Date : | January 11, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Cetuximab nanoparticles goup
A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles
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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.
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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 |
- 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 |
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

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
Contact: Ahmed AH Abdellatif, PhD | +966507726856 ext 14618 | a.abdellatif@qu.edu.sa | |
Contact: Ahmed AH Abdellatif, PhD | +966507726856 ext 2014 | ahmed.a.h.abdellatif@azhar.edu.eg |
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 |
Responsible Party: | Ahmed A. H. Abdellatif, Assistant Professor of Pharmaceutics, Faculty of Pharmacy, Al-Azhar University |
ClinicalTrials.gov Identifier: | NCT03774680 |
Other Study ID Numbers: |
AlAzharCetuximab |
First Posted: | December 13, 2018 Key Record Dates |
Last Update Posted: | October 10, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Colonic Diseases Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |