patients with mCRC with an indication for lonsurf treatment.
Conditions
Interventions
Trade Name: Lonsurf
Pharmaceutical Form: Tablet
Trade Name: Metformin
Product Name: Metformin
Pharmaceutical Form: Tablet
Trade Name: Cimetidine
Product Name: Cimetidine
Pharmaceutical Form: Tablet
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Patients with a confirmed diagnosis of metastatic colorectal cancer with an indication for Lonsurf treatment. 3. WHO performance = 1 4. Able and willing to sign the Informed Consent Form prior to screening evaluations 5. No concurrent medication or supplements which can interact with either Lonsurf, metformin or cimetidine during the study period (e.g. strong OCT2 or MATE1 inhibitors). 6. Abstain from grapefruit, grapefruit juice, herbal dietary supplements, acidic beverages (e.g. Cola) and herbal tea during the study period 7. Adequate baseline patient characteristics (complete blood count, serum biochemistry which involves sodium, potassium, creatinine, calculation of creatinine clearance, AST, ALT, gamma glutamyltranspeptidase, lactate dehydrogenase, ALP, Total bilirubin, Albumin, glucose) 8. BMI 18-30 kg/m2 9. Patients being treated with Lonsurf for any other indication, e.g. as part of experimental treatment in a clinical trial, are also allowed to participate in this trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients 2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 3. Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR<30), serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases) 4. Patient with diabetes mellitus type 2 using metformine as standard of care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the possible drug interaction between Lonsurf and metformin on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer. 2. To determine the possible interaction between Lonsurf and cimetidine on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer. of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.;Secondary Objective: 1. To determine the possible drug interaction between Lonsurf and metformine on metformin plasma trough concentration in patients with metastatic colorectal cancer. 2. Other pharmacokinetic outcomes of both Lonsurf and metformine (i.e. clearance, maximum concentration (Cmax) and time until maximum concentration (tmax)). 3. To evaluate the incidence and severity of side-effects of treatment with Lonsurf in absence and presence of metformin and cimetidine.;Primary end point(s): To determine the influence of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To determine the possible drug interaction between Lonsurf and metformine on metformin plasma trough concentration in patients with metastatic colorectal cancer. 2. Other pharmacokinetic outcomes of both Lonsurf and metformine (i.e. clearance, maximum concentration (Cmax) and time until maximum concentration (tmax)). 3. To evaluate the incidence and severity of side-effects of treatment with Lonsurf in absence and presence of metformin and cimetidine.;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Netherlands
Contacts
Public ContactRon H.J. Mathijssen
Erasmus MC
Outcome results
None listed