Mebendazole as Adjuvant Treatment for Colon Cancer

Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer

mebendazole treating colon cancer

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Folfox with avastin; Drug: Mebendazole

Detailed Description

mebendazole as adjuvant treatment for colon cancer

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Sherief Abd-Elsalam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Colorectal cancer stage 4.

Exclusion Criteria:

• Agranulocytosis
• Pregnancy
• Allergy to mebendazole.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Folfox with avastin; Folfox with avastin only	Drug: Folfox with avastin; Folfox with avastin only; Other Names: folfox 4
Experimental: Mebendazole; Folfox with avastin with mebendazole	Drug: Mebendazole; Folfox with avastin with mebendazole; Other Names: mebendazol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with tumour response	number of patients with response	6 months

Collaborators and Investigators

• Sponsor: Sherief Abd-Elsalam
• Investigators: Principal Investigator: Reham El-ghoneimy, Msc, Tanta University - Faculty of Pharmacy; Principal Investigator: Sahar Hegazy, Prof, Tanta University - Faculty of Pharmacy; Study Director: Gamal el-azab, Prof, Tanta University - Faculty of Pharmacy; Study Chair: Fatma Zakaria, Prof, Clinical Oncology department. Tanta University.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): December 1, 2028
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Bevacizumab; Mebendazole; Piperazine; Piperazine citrate; DMP 777
• Other Study ID Numbers: colon cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No