<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774680</url>
  </required_header>
  <id_info>
    <org_study_id>AlAzharCetuximab</org_study_id>
    <nct_id>NCT03774680</nct_id>
  </id_info>
  <brief_title>Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer</brief_title>
  <official_title>Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed A. H. Abdellatif</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to the great toxicity of chemotherapeutic drugs to both the healthy and cancerous area,&#xD;
      the efficient targeting could be of great benefit for a patient with advanced or metastatic&#xD;
      tumors. Colorectal cells carry somatostatin receptors which make them a promising target for&#xD;
      antitumor therapy since this would reduce side effects and increase drug delivery efficacy to&#xD;
      the target site.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator's aim is to deliver polymeric nanoparticles loaded with anti-cancer drug&#xD;
      Cetuximab and decorated with somatostatin analogue in the form of oral polymeric&#xD;
      nanoparticles, which can release at only above pH 6.8 using ethylcellulose polymer. The&#xD;
      polymeric nanoparticles were prepared using the solvent evaporation method, further will be&#xD;
      characterized for its drug content, size, encapsulation efficiency and drug-loading using UV&#xD;
      spectroscopy. Moreover, the ethylcellulose nanoparticles loaded Cetuximab will release the&#xD;
      Cetuximab at pH above 6.8, while can hold the Cetuximab at pH 1.5 which protecting the&#xD;
      stomach from the toxicity Cetuximab. Then, the nanoparticles will target the colorectal&#xD;
      cancer cells using octreotide, the somatostatin receptor agonist which will lead it to SSTRs&#xD;
      overexpressed in colorectal cancer cells. The strategy of deposition of ligand will depend on&#xD;
      using the advantage of the positive charge surface of nanoparticles which can absorb the&#xD;
      negative charges of the targeting ligands. Final outcomes: this project will present a novel&#xD;
      formulation for the treatment of colorectal cancer which can be delivered safely to the&#xD;
      patients in a high dose to the affected tumor cells with reduced side effects on the other&#xD;
      healthy cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2020</start_date>
  <completion_date type="Anticipated">January 11, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer</measure>
    <time_frame>one year</time_frame>
    <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.&#xD;
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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Colo-rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Cetuximab nanoparticles goup</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral approved anticancer drug</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab nanoparticles</intervention_name>
    <description>The active group will receive cetuximab in nanoparticles as an anti-microbial drug.</description>
    <arm_group_label>Cetuximab nanoparticles goup</arm_group_label>
    <other_name>oral capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral approved anticancer drug</intervention_name>
    <description>The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.</description>
    <arm_group_label>Oral approved anticancer drug</arm_group_label>
    <other_name>oral capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of colon cancer&#xD;
&#xD;
          -  Follow up and collect data for a local and systemic activity of cetuximab&#xD;
&#xD;
          -  The systemic oral capsule of cetuximab be also given to enhance the activity as an&#xD;
             anti-cancer activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peptic ulcer&#xD;
&#xD;
          -  Stomach disease&#xD;
&#xD;
          -  Colon cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed AH Abdellatif, PhD</last_name>
    <phone>+966507726856</phone>
    <phone_ext>14618</phone_ext>
    <email>a.abdellatif@qu.edu.sa</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed AH Abdellatif, PhD</last_name>
    <phone>+966507726856</phone>
    <phone_ext>2014</phone_ext>
    <email>ahmed.a.h.abdellatif@azhar.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut Clinic</name>
      <address>
        <city>Assiut</city>
        <zip>71526</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed AH Abdellatif, PhD</last_name>
      <phone>+966507726856</phone>
      <email>a.abdellatif@qu.edu.sa</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Buraidah Clinic</name>
      <address>
        <city>Buraidah</city>
        <state>Al Qassim</state>
        <zip>51171</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed AH Abdellatif, Ph.D.</last_name>
      <phone>+966507726856</phone>
      <email>a.abdellatif@qu.edu.sa</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Faculty of Pharmacy</name>
      <address>
        <city>Buraidah</city>
        <state>Qassim</state>
        <zip>51452</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed AH Abdellatif, Ph.D.</last_name>
      <phone>+966507726856</phone>
      <email>a.abdellatif@qu.edu.sa</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pharmaceutics dept., Faculty of Pharmacy, Qassim University</name>
      <address>
        <city>Buraidah</city>
        <state>Qassim</state>
        <zip>51452</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed AH Abdellatif, Ph.D.</last_name>
      <phone>+966507726856</phone>
      <email>a.abdellatif@qu.edu.sa</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
    <country>Saudi Arabia</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>29881409</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>27032509</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>25467588</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Ahmed A. H. Abdellatif</investigator_full_name>
    <investigator_title>Assistant Professor of Pharmaceutics, Faculty of Pharmacy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetuximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774680
org study id: AlAzharCetuximab
nct id: NCT03774680
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer
time frame: one year
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.
arm group label: Cetuximab nanoparticles goup
arm group type: Active Comparator
description: A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles
arm group label: Oral approved anticancer drug
arm group type: Placebo Comparator
description: A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.
intervention type: Drug
intervention name: Cetuximab nanoparticles
description: The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
arm group label: Cetuximab nanoparticles goup
other name: oral capsules
intervention type: Drug
intervention name: Oral approved anticancer drug
description: The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
arm group label: Oral approved anticancer drug
other name: oral capsules
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed AH Abdellatif, PhD
phone: +966507726856
phone ext: 14618
email: a.abdellatif@qu.edu.sa
last name: Ahmed AH Abdellatif, PhD
phone: +966507726856
phone ext: 2014
email: ahmed.a.h.abdellatif@azhar.edu.eg
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Egypt
country: Saudi Arabia
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.
PMID: 29881409
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.
PMID: 27032509
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.
PMID: 25467588
responsible party type: Sponsor-Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed A. H. Abdellatif
investigator title: Assistant Professor of Pharmaceutics, Faculty of Pharmacy
mesh term: Colonic Neoplasms
mesh term: Cetuximab
sharing ipd: Undecided