NCT03925662

Brief Summary

mebendazole treating colon cancer

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
32mo left

Started Apr 2019

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress73%
Apr 2019Dec 2028

Study Start

First participant enrolled

April 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

9.7 years

First QC Date

April 22, 2019

Last Update Submit

April 22, 2019

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • number of patients with tumour response

    number of patients with response

    6 months

Study Arms (2)

Folfox with avastin

ACTIVE COMPARATOR

Folfox with avastin only

Drug: Folfox with avastin

Mebendazole

EXPERIMENTAL

Folfox with avastin with mebendazole

Drug: Mebendazole

Interventions

Folfox with avastinDRUG

Folfox with avastin only

Also known as: folfox 4
Folfox with avastin
MebendazoleDRUG

Folfox with avastin with mebendazole

Also known as: mebendazol
Mebendazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer stage 4.

You may not qualify if:

  • Agranulocytosis
  • Pregnancy
  • Allergy to mebendazole.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35385794DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocolBevacizumabMebendazole

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Reham El-ghoneimy, Msc

    Tanta University - Faculty of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Sahar Hegazy, Prof

    Tanta University - Faculty of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Gamal el-azab, Prof

    Tanta University - Faculty of Pharmacy

    STUDY DIRECTOR

  • Fatma Zakaria, Prof

    Tanta University

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

April 1, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)