Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Gastrointestinal Neoplasms

Digestive System Neoplasms

Carcinoma

Neoplasms, Unknown Primary

Gastrointestinal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Mebendazole

Anthelmintics

Antiparasitic Agents

Tubulin Modulators

Antimitotic Agents

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.

ReposMBZ

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.

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.

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

Genetic changes and infiltration of immune cells, grade, molecular subtype, gene and protein expression and tumour infiltration and subtypes of macrophages and lymphocytes.

Changes in the properties analysed in the archived tissue (baseline) and the fresh biopsy.

Mean S-mebendazole concentration during treatment phase in relation to safety (CTCAE 4.03 grade 3 and 4 toxicity) and efficacy (tumour response and TTP) respectively.

Blood chemistry (plasma): Sodium, Potassium, Calcium, Glucose (mmol/L)

Blood chemistry (plasma): Bilirubin (µmol/L)

Blood chemistry (plasma): ALAT, ASAT, LDH, ALP (µkat/L)

Haematology: RBC (red blood cell count), White blood cells with differential count and platelets (absolute count/L)

Coagulation (plasma): Prothrombin complex (INR)

Systolic and diastolic blood pressure (mmHg) Weight (kg)

Best overall radiological response Time to tumour progression (TTP) compared with TTP on the treatment just preceding this protocol.

Cmax will be used to decide the starting dose in the treatment phase.

Analysis of serum concentration after single dose administration of ReposMBZ.

Cmax will be used to adjust the dose until target S-mebendazole level is reached and to show the individual variation of S-mebendazole concentration over time

Number of patients that reach the steady state S-mebendazole target concentration.

Time from first dose in treatment phase until target S-mebendazole concentration is reached

Change of cytokine levels in blood, evaluated by cytokine array.

Up-regulation of activation markers compared to baseline, evaluated by flow cytometry.

Spots Global Cancer Trial Database for reposmbz

Every month we try and update this database with for reposmbz cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for reposmbz

Every month we try and update this database with for reposmbz cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for reposmbz cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.