A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.

Last updated: January 18, 2020
Sponsor: Repos Pharma
Overall Status: Terminated

Phase

1/2

Condition

Stomach Cancer

Gastric Ulcers

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT03628079
RP-2017-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofunknown origin.

  3. Measurable disease according to RECIST 1.1.

  4. Defined time to tumour progression on the standard/experimental treatment precedingthe 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.

    • (removed via Amendment 1)
  6. Pharmacological treatment attempt considered reasonable.

  7. Females of childbearing potential should use adequate contraception throughout thestudy;

  8. Combined (estrogen and progestogen containing) hormonal contraception associatedwith inhibition of ovulation (oral, intravaginal or transdermal)

  9. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)

  10. Intrauterine device (IUD)

  11. Intrauterine hormone-releasing system (IUS)

  12. Bilateral tubal occlusion

  13. Vasectomized partner

  14. Sexual abstinence

  15. Signed informed consent.

Exclusion

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 theinvestigator, 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.:

  6. neutrophils ≤ 1,3 x 109/l

  7. platelets ≤ 100 x 109/l

  8. bilirubin > 1.5 x upper limit of normal (ULN)

  9. Alanine aminotransferase (ALAT) > 5 x ULN

  10. Glomerular filtration rate (GFR) <50 ml/min (calculated from P-creatinine)

  11. Prothrombin complex/INR outside normal range

  12. Current active participation in any other interventional clinical study.

  13. Contraindications to the investigational product, e.g. known or suspectedhypersensitivity or inability to oral drug administration.

  14. Pregnancy or lactation.

  15. Lack of suitability for participation in the study, e g expected difficulties tofollow the protocol procedures, as judged by the Investigator.

Study Design

Total Participants: 11
Study Start date:
May 25, 2018
Estimated Completion Date:
January 16, 2019

Study 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.

Connect with a study center

  • Dept of oncology, University Hospital

    Uppsala, 75185
    Sweden

    Site Not Available

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