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About
This study will evaluate the safety and efficacy of mebendazole (ReposMBZ) in patient with advanced gastrointestinal cancer or cancer of unknown origin. All patients will be given ReposMBZ for 16 weeks continuous treatment, individually dosed based on the serum concentration of mebendazole.
Full description
Mebendazole has been used extensively during long time for local gut helminthic infections at low dose but also at considerably higher doses during months to years against invasive echinococcus infections. Recent research has now clearly indicated that mebendazole has anticancer effect. Given these observations and the experience of excellent tolerance to mebendazole the current clinical trial protocol is based on the repositioning strategy to more extensively investigate whether mebendazole could be developed into a useful anticancer drug.
Enrollment
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Volunteers
Inclusion criteria
At least 18 years of age.
Histologically confirmed diagnosis of squamous cell cancer or adenocarcinoma, including primary cancer of the liver, of the gastrointestinal tract or cancer of unknown origin.
Measurable disease according to RECIST 1.1.
Defined time to tumour progression on the standard/experimental treatment preceding the trial treatment.
Locally advanced or metastatic disease not amenable to standard treatment, i.e. progress on standard therapy or observed/expected intolerance to standard therapy.
Pharmacological treatment attempt considered reasonable.
Females of childbearing potential should use adequate contraception throughout the study;
Signed informed consent.
Exclusion criteria
Anti-tumour therapy within 3 weeks prior to study drug administration day
Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient.
WHO performance status ≥ 2.
Child-Pugh B or C liver function status if hepatocellular carcinoma.
Inadequate laboratory parameters reflecting major organ function i.e.:
Current active participation in any other interventional clinical study.
Contraindications to the investigational product, e.g. known or suspected hypersensitivity or inability to oral drug administration.
Pregnancy or lactation.
Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the Investigator.
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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