Cancer of the Gastrointestinal TractPhase 1/2RepoMebNCT03628079
A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.
A Phase 1/2 study testing ReposMBZ in people with Cancer of the Gastrointestinal Tract and Cancer of Unknown Origin, run by Repos Pharma at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Gastrointestinal Tract, Cancer of Unknown Origin
- What is being tested?
- ReposMBZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- 25 May 2018to 16 Jan 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 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.
- - (removed via Amendment 1)
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- Pharmacological treatment attempt considered reasonable.
- Females of childbearing potential should use adequate contraception throughout the study;
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence
- Signed informed consent.
Who cannot join
- 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.:
- neutrophils ≤ 1,3 x 109/l
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- platelets ≤ 100 x 109/l
- bilirubin > 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALAT) > 5 x ULN
- Glomerular filtration rate (GFR) <50 ml/min (calculated from P-creatinine)
- Prothrombin complex/INR outside normal range
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed 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.
- Being tested
- ReposMBZ
- Medical subject headings
- Gastrointestinal Neoplasms, Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReposMBZDrug
Also called Mebendazole
Capsules 50mg, 100mg, 200mg
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | 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. Receives: Drug: ReposMBZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) probably or possibly related to ReposMBZ
AEs graded according to CTCAE 4.03.
Measured: 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.
Changes in plasma Albumin over time
Blood Chemistry (plasma): Albumin (g/L)
Measured: 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.
Changes in C-reactive protein (CRP) over time
Blood chemistry (plasma): CRP (mg/L)
Measured: 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.
Changes in plasma Sodium, Potassium, Calcium and Glucose over time
Blood chemistry (plasma): Sodium, Potassium, Calcium, Glucose (mmol/L)
Measured: 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.
Changes in plasma Bilirubin over time
Blood chemistry (plasma): Bilirubin (µmol/L)
Measured: 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.
Changes in plasma ALAT (alanine aminotransferase), ASAT (aspartate aminotransferase), LDH (lactate dehydrogenase), ALP (alkaline phosphatase) over time
Blood chemistry (plasma): ALAT, ASAT, LDH, ALP (µkat/L)
Measured: 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.
Changes in Haemoglobin over time
Haematology: Haemoglobin (g/L)
Measured: 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.
Changes in red, white and platelet blood cell count over time
Haematology: RBC (red blood cell count), White blood cells with differential count and platelets (absolute count/L)
Measured: 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.
Changes in Activated Partial Thromboplastin Time (APTT) over time
Coagulation (plasma): APTT (s)
Measured: 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.
Changes in Prothrombin complex (PK/INR) over time
Coagulation (plasma): Prothrombin complex (INR)
Measured: 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.
Changes in blood pressure over time
Systolic and diastolic blood pressure (mmHg) Weight (kg)
Measured: 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.
Changes in heart rate over time
Supine heart rate (beats per minute)
Measured: 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.
Changes in body temperature over time.
Body temperature (Celsius degrees)
Measured: 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.
Tumour response: CT/MRI assessed according to RECIST 1.1
Best overall radiological response Time to tumour progression (TTP) compared with TTP on the treatment just preceding this protocol.
Measured: From date of first dose ReposMBZ until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months (end of study).
Secondary outcomes (9)
The peak serum concentration (Cmax) of ReposMBZ after single dose administration.
Cmax will be used to decide the starting dose in the treatment phase.
Measured: Pre-dose, 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours.
Area under the serum concentration versus time curve (AUC) for ReposMBZ
Analysis of serum concentration after single dose administration of ReposMBZ.
Measured: Pre-dose, 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours.
The Cmax serum concentration of ReposMBZ after repeated dose administration.
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
Measured: Pre-dose, 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours (only up to the time point for Cmax after single dose), assessed up to 16 weeks after start of treatment phase.
Target S-mebendazole concentration after repeated dose administration.
Number of patients that reach the steady state S-mebendazole target concentration.
Measured: From first dose in treatment phase and assessed up to 16 weeks after start of treatment phase.
Time to reach the steady state S-mebendazole target concentration after repeated dose administration..
Time from first dose in treatment phase until target S-mebendazole concentration is reached
Measured: From first dose in treatment phase and assessed up to 16 weeks after start of treatment phase.
Systemic immune activation.
Change of cytokine levels in blood, evaluated by cytokine array.
Measured: From baseline up to 20 weeks after start of treatment phase, assessed up to 24 months (end of study).
Immune cell activation.
Up-regulation of activation markers compared to baseline, evaluated by flow cytometry.
Measured: From baseline and up to 20 weeks after start of treatment phase, assessed up to 24 months (end of study).
Overall survival.
Months of survival from first dose until death of any cause.
Measured: From date of first dose ReposMBZ to date of death, assessed up to 24 months (end of study).
Change in tumour load and TTP according to irRECIST
Best over all radiological response according to irRECIST 1.1.
Measured: From date of first dose ReposMBZ until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months (end of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start25 May 2018
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Why it stopped: Lack of effect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Gastrointestinal TractStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repos Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala University, Uppsala University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628079
- Sponsor's protocol ID
- RP-2017-001
- Acronym
- RepoMeb
- Status last verified
- Jan 2020
- First submitted
- 17 Jun 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03628079
- Acronym / sponsor ID
- RepoMeb / RP-2017-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of effect
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Repos PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala University, Uppsala University Hospital
- Study start
- 25 May 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 14 Aug 2018 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Drug: ReposMBZReposMBZ 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.:
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 |
|---|---|---|
| ReposMBZAlso: MebendazoleCapsules 50mg, 100mg, 200mg | Drug | Single arm study |
Primary outcome
Incidence of adverse events (AEs) probably or possibly related to ReposMBZ
Time frame: 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.
AEs graded according to CTCAE 4.03.
Changes in plasma Albumin over time
Time frame: 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.
Blood Chemistry (plasma): Albumin (g/L)
Changes in C-reactive protein (CRP) over time
Time frame: 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.
Blood chemistry (plasma): CRP (mg/L)
Changes in plasma Sodium, Potassium, Calcium and Glucose over time
Time frame: 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.
Blood chemistry (plasma): Sodium, Potassium, Calcium, Glucose (mmol/L)
Changes in plasma Bilirubin over time
Time frame: 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.
Blood chemistry (plasma): Bilirubin (µmol/L)
Changes in plasma ALAT (alanine aminotransferase), ASAT (aspartate aminotransferase), LDH (lactate dehydrogenase), ALP (alkaline phosphatase) over time
Time frame: 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.
Blood chemistry (plasma): ALAT, ASAT, LDH, ALP (µkat/L)
Changes in Haemoglobin over time
Time frame: 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.
Haematology: Haemoglobin (g/L)
Changes in red, white and platelet blood cell count over time
Time frame: 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.
Haematology: RBC (red blood cell count), White blood cells with differential count and platelets (absolute count/L)
Changes in Activated Partial Thromboplastin Time (APTT) over time
Time frame: 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.
Coagulation (plasma): APTT (s)
Changes in Prothrombin complex (PK/INR) over time
Time frame: 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.
Coagulation (plasma): Prothrombin complex (INR)
Changes in blood pressure over time
Time frame: 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.
Systolic and diastolic blood pressure (mmHg) Weight (kg)
Changes in heart rate over time
Time frame: 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.
Supine heart rate (beats per minute)
Changes in body temperature over time.
Time frame: 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.
Body temperature (Celsius degrees)
Tumour response: CT/MRI assessed according to RECIST 1.1
Time frame: From date of first dose ReposMBZ until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months (end of study).
Best overall radiological response Time to tumour progression (TTP) compared with TTP on the treatment just preceding this protocol.
9 secondary outcomes
The peak serum concentration (Cmax) of ReposMBZ after single dose administration.
Time frame: Pre-dose, 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours.
Area under the serum concentration versus time curve (AUC) for ReposMBZ
Time frame: Pre-dose, 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours.
The Cmax serum concentration of ReposMBZ after repeated dose administration.
Time frame: Pre-dose, 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours (only up to the time point for Cmax after single dose), assessed up to 16 weeks after start of treatment phase.
Target S-mebendazole concentration after repeated dose administration.
Time frame: From first dose in treatment phase and assessed up to 16 weeks after start of treatment phase.
Time to reach the steady state S-mebendazole target concentration after repeated dose administration..
Time frame: From first dose in treatment phase and assessed up to 16 weeks after start of treatment phase.
Systemic immune activation.
Time frame: From baseline up to 20 weeks after start of treatment phase, assessed up to 24 months (end of study).
Immune cell activation.
Time frame: From baseline and up to 20 weeks after start of treatment phase, assessed up to 24 months (end of study).
Overall survival.
Time frame: From date of first dose ReposMBZ to date of death, assessed up to 24 months (end of study).
Change in tumour load and TTP according to irRECIST
Time frame: From date of first dose ReposMBZ until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months (end of study).
Results and safety
The study was stopped early (reason given: Lack of effect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ReposMBZ in people with Cancer of the Gastrointestinal Tract and Cancer of Unknown Origin, run by Repos Pharma at 1 site in Sweden.
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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Jan 2020. 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 Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of effect). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) probably or possibly related to ReposMBZ (time frame: 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.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.