renal cell carcinoma soft tissue sarcoma
Conditions
Interventions
Patients will receive pazopanib 400mg BID for a period of one week (instead of
800mg QD).
Pazopanib
Pharmacokinetics
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Histological or cytological proof of cancer for which pazopanib is considered standard care; 2. Patients should have received pazopanib 800 mg QD as routine care for at least 3 weeks before day 1 of the trial; 3. Age * 18 years; 4. Able and willing to give written informed consent; 5. WHO performance status of 0, 1 or 2; 6. Adequate organ function per judgement of the treating physician; 7. Able and willing to undergo blood sampling for PK analysis.
Exclusion criteria
Exclusion criteria: 1. Concomitant use of medication(s) which could influence the pharmacokinetics of pazopanib within 14 days or five half-lives of the drug (whichever is shorter) before start of the study, consisting of (but not limited to) gastric acid suppressing agents, CYP3A4-inhibitors/inductors, PgP and/or BCRP modulators. In particular, proton pump inhibitors (such as omeprazole and pantoprazole) are to be avoided; 2. Woman who are pregnant or breast feeding; 3. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance; 4. Pazopanib related side effects that would require a dose reduction per judgement of the treating physician; 5. Legal incapacity; 6. (Calculated) pazopanib Cmin > 33 mg/L at screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the increase in Cmin and AUC when comparing pazopanib 800mg QD and 400mg BID. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the incidence and severity of adverse events between the two dosing schedules, according to CTC-AE v4.03. | — |
Countries
The Netherlands
Outcome results
None listed