Advanced renal cell carcinoma
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced or metastatic cancer; 2. Age >= 18 years; 3. Able and willing to give written informed consent; 4. WHO performance status of 0, 1 or 2; 5. Able and willing to undergo blood sampling for PK analysis; 6. Minimal acceptable safety laboratory values a. ANC of >= 1.5 x 109 /L b. Platelet count of >= 100 x 109 /L c. Hepatic function as defined by serum bilirubin = 50 ml/min (by Cockcroft-Gault formula). 7. Negative pregnancy test (urine/serum) for female patients with childbearing potential; 8. Able and willing to swallow oral medication;
Exclusion criteria
Exclusion criteria: 1. Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment; 2. Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, claritromycine, erytromycine, indinavir, itraconazol, ketoconazol, ritonavir and voriconazol), inhibitors of Pgp (e.g. ciclosporine, kinidine and verapamil), inhibitors of BCRP (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP or stomach pH increasing drugs; 3. Patients who have had previous treatment with Votrient®, less than 1 week ago; 4. Woman who are pregnant or breast feeding; 5. Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of Pazopanib (e.g. dyspepsia, inflammatory bowel disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be the concentration of Pazopanib in patient plasma. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second study parameter will be the preliminary safety assessment of PazSol001. | — |
Countries
Netherlands
Outcome results
None listed