Colorectal CancerPhase 3NCT03925662
Mebendazole as Adjuvant Treatment for Colon Cancer
A Phase 3 study testing Folfox with avastin and Mebendazole in people with Colorectal Cancer, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
mebendazole treating colon cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Folfox with avastin and Mebendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer stage 4.
Who cannot join
- Agranulocytosis
- Pregnancy
- Allergy to mebendazole.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Cairo
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer
mebendazole treating colon cancer
Read the detailed description
mebendazole as adjuvant treatment for colon cancer
- Conditions
- Colorectal Cancer
- Being tested
- Folfox with avastin, Mebendazole
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folfox with avastinDrug
Also called folfox 4
Folfox with avastin only
MebendazoleDrug
Also called mebendazol
Folfox with avastin with mebendazole
| Study group | Role | What they receive |
|---|---|---|
| Folfox with avastin | Active comparator | Folfox with avastin only Receives: Drug: Folfox with avastin |
| Mebendazole | Experimental | Folfox with avastin with mebendazole Receives: Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with tumour response
number of patients with response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Apr 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Reham El-ghoneimy, Msc, Principal investigator, Tanta University - Faculty of PharmacySahar Hegazy, Prof, Principal investigator, Tanta University - Faculty of PharmacyGamal el-azab, Prof, Study director, Tanta University - Faculty of PharmacyFatma Zakaria, Prof, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925662
- Sponsor's protocol ID
- colon cancer
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35385794
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03925662
- Acronym / sponsor ID
- colon cancer
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Apr 2019 (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.
mebendazole treating colon cancer
Detailed description
mebendazole as adjuvant treatment for colon cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folfox with avastin | Active comparator | Drug: Folfox with avastinFolfox with avastin only |
| Mebendazole | Experimental | Drug: MebendazoleFolfox with avastin with mebendazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal cancer stage 4.
Key exclusion criteria (3 listed)
- Agranulocytosis
- Pregnancy
- Allergy to mebendazole.
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 |
|---|---|---|
| Folfox with avastinAlso: folfox 4Folfox with avastin only | Drug | Folfox with avastin |
| MebendazoleAlso: mebendazolFolfox with avastin with mebendazole | Drug | Mebendazole |
Primary outcome
number of patients with tumour response
Time frame: 6 months
number of patients with response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 35385794Hegazy 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.
- Individual participant dataSharing planned: No
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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.
Reham El-ghoneimy, Msc principal investigator
Tanta University - Faculty of Pharmacy
Sahar Hegazy, Prof principal investigator
Tanta University - Faculty of Pharmacy
Gamal el-azab, Prof study director
Tanta University - Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folfox with avastin and Mebendazole in people with Colorectal Cancer, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with tumour response (time frame: 6 months). 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 NCT03925662, which also lists 1 linked publication.
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 24 Apr 2019.