NCT03774680

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

Same day

First QC Date

December 11, 2018

Last Update Submit

October 9, 2019

Conditions

Colon CancerColo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cetuximab nanoparticles goup

ACTIVE COMPARATOR

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

Drug: Cetuximab nanoparticles

Oral approved anticancer drug

PLACEBO COMPARATOR

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

Drug: Oral approved anticancer drug

Interventions

Cetuximab nanoparticlesDRUG

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

Also known as: oral capsules
Cetuximab nanoparticles goup
Oral approved anticancer drugDRUG

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

Also known as: oral capsules
Oral approved anticancer drug

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Peptic ulcer
  • Stomach disease
  • Colon cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Assiut Clinic

Asyut, 71526, Egypt

RECRUITING

Buraidah Clinic

Buraidah, Al Qassim, 51171, Saudi Arabia

RECRUITING

Faculty of Pharmacy

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

RECRUITING

Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29881409RESULT

  • 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.

    PMID: 27032509RESULT

  • 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.

    PMID: 25467588RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Capsules

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Central Study Contacts

Ahmed AH Abdellatif, PhD

CONTACT

+966507726856a.abdellatif@qu.edu.sa

Ahmed AH Abdellatif, PhD

CONTACT

+966507726856ahmed.a.h.abdellatif@azhar.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Pharmaceutics, Faculty of Pharmacy

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

February 1, 2020

Primary Completion

February 1, 2020

Study Completion

January 11, 2021

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations

EG(1)SA(3)