cancer malignancies
Conditions
Interventions
Patients will start receiving once daily oral sunitinib, dosed according to the
standard dosing schedule of 37.5 mg continuous daily dosing.
On two fixed timepoints during the study there is a possi
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histopathologically confirmed advanced or metastatic solid tumors for whom sunitinib is standard therapy, of for whom no standard therapy is available;2. Age >= 18 years;;3. Able and willing to give written informed consent;;4. Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis;;5. Able to swallow oral medications;6. Life expectancy >= 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;;7. WHO performance status of 0 or 1;;8. Evaluable disease according to RECIST 1.1 criteria;;9. Minimal acceptable safety laboratory values • ANC of >= 1.5 x 109 /L • Platelet count of >= 100 x 109 /L • Hepatic function as defined by serum bilirubin = 50 mL/min (by Cockcroft-Gault formula);;10. No radio- or chemotherapy or other investigational drug treatment within the last 4 weeks prior to study entry, with the exception of palliative radiotherapy (8Gy, or in the extremities).
Exclusion criteria
Exclusion criteria: 1. Current treatment in another therapeutic clinical trial;2. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication;3. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up;4. Women who are pregnant or breast feeding.;5. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (definition of adequate contraceptive methods will be based on the judgment of the principal investigator or a designated associate). ;6. Legal incapacity.;7. Known allergy/intolerance to sunitinib or any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response (RECIST): ORR, PR, TTP, PFS Toxicity (CTC v4.2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (dried blood spots): total trough levels Pharmacogenetics: polymorfism of genes involved in pharmacokinetic and pharmacodynamic pathways. | — |
Countries
Netherlands
Outcome results
None listed