Back to resultsMebendazole as Adjuvant Treatment for Colon Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Folfox with avastin
Mebendazole
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Colorectal cancer stage 4.
Exclusion Criteria:
- Agranulocytosis
- Pregnancy
- Allergy to mebendazole.
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Folfox with avastin
Mebendazole
Arm Description
Folfox with avastin only
Folfox with avastin with mebendazole
Outcomes
Primary Outcome Measures
number of patients with tumour response
number of patients with response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03925662
Brief Title
Mebendazole as Adjuvant Treatment for Colon Cancer
Official Title
Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
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
mebendazole treating colon cancer
Detailed Description
mebendazole as adjuvant treatment for colon cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Folfox with avastin
Arm Type
Active Comparator
Arm Description
Folfox with avastin only
Arm Title
Mebendazole
Arm Type
Experimental
Arm Description
Folfox with avastin with mebendazole
Intervention Type
Drug
Intervention Name(s)
Folfox with avastin
Other Intervention Name(s)
folfox 4
Intervention Description
Folfox with avastin only
Intervention Type
Drug
Intervention Name(s)
Mebendazole
Other Intervention Name(s)
mebendazol
Intervention Description
Folfox with avastin with mebendazole
Primary Outcome Measure Information:
Title
number of patients with tumour response
Description
number of patients with response
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal cancer stage 4.
Exclusion Criteria:
Agranulocytosis
Pregnancy
Allergy to mebendazole.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham El-ghoneimy, Msc
Organizational Affiliation
Tanta University - Faculty of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar Hegazy, Prof
Organizational Affiliation
Tanta University - Faculty of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gamal el-azab, Prof
Organizational Affiliation
Tanta University - Faculty of Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatma Zakaria, Prof
Organizational Affiliation
Clinical Oncology department. Tanta University.
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35385794
Citation
Hegazy SK, El-Azab GA, Zakaria F, Mostafa MF, El-Ghoneimy RA. Mebendazole; from an anti-parasitic drug to a promising candidate for drug repurposing in colorectal cancer. Life Sci. 2022 Jun 15;299:120536. doi: 10.1016/j.lfs.2022.120536. Epub 2022 Apr 3.
Results Reference
derived
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Mebendazole as Adjuvant Treatment for Colon Cancer
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