Colon CancerPhase 1NCT03774680
Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer
A Phase 1 study testing Cetuximab nanoparticles and Oral approved anticancer drug in people with Colon Cancer and Colo-rectal Cancer, run by Ahmed A. H. Abdellatif at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Colo-rectal Cancer
- What is being tested?
- Cetuximab nanoparticles and Oral approved anticancer drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Feb 2020to 11 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Peptic ulcer
- Stomach disease
- Colon cancer
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Saudi Arabia3 sites, 3 recruiting
- Recruiting
Buraidah Clinic
Buraidah, Al Qassim, 51171
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
- Recruiting
Faculty of Pharmacy
Buraidah, Al-Qassim Region, 51452
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
- Recruiting
Pharmaceutics dept., Faculty of Pharmacy, Qassim University
Buraidah, Al-Qassim Region, 51452
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
Egypt1 site, 1 recruiting
- Recruiting
Assiut Clinic
Asyut, 71526
Ahmed AH Abdellatif, PhD, +966507726856, a.abdellatif@qu.edu.sa
About this study
Official title: Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer
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.
Read the 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.
- Conditions
- Colon Cancer, Colo-rectal Cancer
- Being tested
- Cetuximab nanoparticles, Oral approved anticancer drug
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab nanoparticlesDrug
Also called oral capsules
The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
Oral approved anticancer drugDrug
Also called oral capsules
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab nanoparticles goup | Active comparator | A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles Receives: Drug: Cetuximab nanoparticles |
| Oral approved anticancer drug | Placebo comparator | A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug. Receives: Drug: Oral approved anticancer drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion11 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed A. H. Abdellatif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed A. H. Abdellatif, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774680
- Sponsor's protocol ID
- AlAzharCetuximab
- Status last verified
- Oct 2019
- First submitted
- 11 Dec 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29881409Abdellatif 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.
PubMed 27032509Allemani 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.
PubMed 25467588
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer
- ClinicalTrials.gov ID
- NCT03774680
- Acronym / sponsor ID
- AlAzharCetuximab
- Conditions
- Colon Cancer, Colo-rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahmed A. H. AbdellatifUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 11 Jan 2021 (estimated)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab nanoparticles goup | Active comparator | Drug: Cetuximab nanoparticlesA group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles |
| Oral approved anticancer drug | Placebo comparator | Drug: Oral approved anticancer drugA group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Peptic ulcer
- Stomach disease
- Colon cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab nanoparticlesAlso: oral capsulesThe active group will receive cetuximab in nanoparticles as an anti-microbial drug. | Drug | Cetuximab nanoparticles goup |
| Oral approved anticancer drugAlso: oral capsulesThe placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug. | Drug | Oral approved anticancer drug |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Results publication: PubMed 29881409Hafez 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 publication: PubMed 27032509Abdellatif 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 publication: PubMed 25467588Allemani 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.
- Individual participant dataSharing planned: Undecided
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab nanoparticles and Oral approved anticancer drug in people with Colon Cancer and Colo-rectal Cancer, run by Ahmed A. H. Abdellatif at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed AH Abdellatif, PhD (+966507726856 ext. 14618, a.abdellatif@qu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774680, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.