Clinical trial · Interventional
A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.
A Phase 2a TDM-guided Clinical Study on the Safety and Efficacy of Mebendazole in Patients With Advanced Gastrointestinal Cancer or Cancer of Unknown Origin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of effect
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Gastrointestinal Tract | — | UNRESOLVED | — |
| Cancer of Unknown Origin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ReposMBZ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm study
- description
- ReposMBZ 100 mg capsule by mouth followed by 8h PK sampling to decide the initial daily dose. Treatment: Repos MBZ capsules by mouth twice daily for 16 weeks, daily dose 50mg-4g, based on the serum level of mebendazole.
- interventionNames
- Drug: ReposMBZ
Primary outcomes (14)
- measure
- Incidence of adverse events (AEs) probably or possibly related to ReposMBZ
- timeFrame
- From date of first dose, up to 30 days after last dose of ReposMBZ or start of new treatment, whatever comes first, assessed up to 20 weeks after start of treatment phase.
- description
- AEs graded according to CTCAE 4.03.
- measure
- Changes in plasma Albumin over time
- timeFrame
- From date of first dose, up to 30 days after last dose of ReposMBZ or start of new treatment, whatever comes first, assessed up to 20 weeks after start of treatment phase.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least 18 years of age. 2. Histologically confirmed diagnosis of squamous cell cancer or adenocarcinoma, including primary cancer of the liver, of the gastrointestinal tract or cancer of unknown origin. 3. Measurable disease according to RECIST 1.1. 4. Defined time to tumour progression on the standard/experimental treatment preceding the trial treatment. 5. Locally advanced or metastatic disease not amenable to standard treatment, i.e. progress on standard therapy or observed/expected intolerance to standard therapy. 6. \- (removed via Amendment 1) 7. Pharmacological treatment attempt considered reasonable. 8. Females of childbearing potential should use adequate contraception throughout the study; 1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal) 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable) 3. Intrauterine device (IUD) 4. Intrauterine hormone-releasing system (IUS) 5. Bilateral tubal occlusion 6. Vasectomized partner 7. Sexual abstinence 9. Signed informed consent. Exclusion Criteria: 1. Anti-tumour therapy within 3 weeks prior to study drug administration day 2. Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient. 3. WHO performance status ≥ 2. 4. Child-Pugh B or C liver function status if hepatocellular carcinoma. 5. Inadequate laboratory parameters reflecting major organ function i.e.: 1. neutrophils ≤ 1,3 x 109/l 2. platelets ≤ 100 x 109/l 3. bilirubin \> 1.5 x upper limit of normal (ULN) 4. Alanine aminotransferase (ALAT) \> 5 x ULN 5. Glomerular filtration rate (GFR) \<50 ml/min (calculated from P-creatinine) 6. Prothrombin complex/INR outside normal range 6. Current active participation in any other interventional clinical study. 7. Contraindications to the investigational product, e.g. known or suspected hypersensitivity or inability to oral drug administration. 8. Pregnancy or lactation. 9. Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the Investigator.
References
Publications (0)
Data not yet available