Patients for whom pazopanib is considered standard care (advanced renal cell carcinoma and advanced soft-tissue sarcoma).
Conditions
Interventions
Trade Name: Votrient
Pharmaceutical Form: Tablet
Sponsors
Netherlands Cancer Institute
Eligibility
Sex/Gender
All
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 or older; 4. Able and willing to give written informed consent; 5. WHO performance status of 0, 1 or 2; 6. Adequate organ function as per judgement of the treating physician; 7. Able and willing to undergo blood sampling for PK analysis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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 |
|---|---|
| Main Objective: To show whether switching patients from a once daily (QD) to a twice daily (BID) dosing schedule will lead to a significant increase in pharmacokinetic exposure, measured as Cmin and AUC0-24h.;Secondary Objective: To compare the incidence and severity of adverse events between the two dosing schedules, according to CTC-AE v4.03;Primary end point(s): Increase in pharmacokinetic exposure, measured as Cmin and AUC0-24h, when switching patients from a once daily (QD) dosing scheme to a twice daily (BID) dosing scheme.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare the incidence and severity of adverse events between the two dosing schedules, according to CTC-AE v4.03.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactSteffie Groenland
Netherlands Cancer Institute
Outcome results
None listed