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

Primary Purpose

Colon Cancer, Colo-rectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cetuximab nanoparticles
Oral approved anticancer drug
Sponsored by
Ahmed A. H. Abdellatif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assiut ClinicRecruiting
  • Buraidah ClinicRecruiting
  • Faculty of PharmacyRecruiting
  • Pharmaceutics dept., Faculty of Pharmacy, Qassim UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cetuximab nanoparticles goup

Oral approved anticancer drug

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
October 9, 2019
Sponsor
Ahmed A. H. Abdellatif
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1. Study Identification

Unique Protocol Identification Number
NCT03774680
Brief Title
Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer
Official Title
Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
January 11, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed A. H. Abdellatif

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colo-rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab nanoparticles goup
Arm Type
Active Comparator
Arm Description
A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles
Arm Title
Oral approved anticancer drug
Arm Type
Placebo Comparator
Arm Description
A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.
Intervention Type
Drug
Intervention Name(s)
Cetuximab nanoparticles
Other Intervention Name(s)
oral capsules
Intervention Description
The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
Intervention Type
Drug
Intervention Name(s)
Oral approved anticancer drug
Other Intervention Name(s)
oral capsules
Intervention Description
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
Primary Outcome Measure Information:
Title
Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AH Abdellatif, PhD
Phone
+966507726856
Ext
14618
Email
a.abdellatif@qu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AH Abdellatif, PhD
Phone
+966507726856
Ext
2014
Email
ahmed.a.h.abdellatif@azhar.edu.eg
Facility Information:
Facility Name
Assiut Clinic
City
Assiut
ZIP/Postal Code
71526
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, PhD
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
Facility Name
Buraidah Clinic
City
Buraidah
State/Province
Al Qassim
ZIP/Postal Code
51171
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
Facility Name
Faculty of Pharmacy
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
Facility Name
Pharmaceutics dept., Faculty of Pharmacy, Qassim University
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29881409
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.
Results Reference
result
PubMed Identifier
27032509
Citation
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.
Results Reference
result
PubMed Identifier
25467588
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, 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. Erratum In: Lancet. 2015 Mar 14;385(9972):946.
Results Reference
result

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

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