No registrations found.
ID
Source
Brief title
Health condition
Patients for who treatment with pazopanib is considered standard care (renal cell carcinoma and soft-tissue sarcoma).
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the trial is 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 outcome
The secondary objective of the trial is to compare the incidence and severity of adverse events between the two dosing schedules, according to CTC-AE v4.03
Background summary
In the N17PSI we will study whether switching patients from pazopanib 800 mg QD to 400mg BID will increase the Cmin and AUC. This is relevant, because at the current dose of 800 mg QD approximately 20.0 - 57% of patients do not reach the pharmacokinetic target of Cmin > 20 mg/L.
Study objective
The aim of this study is 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.
Study design
NA
Intervention
The intervention of the study consists of splitting the intake moments of pazopanib for one week into 400 mg BID instead of 800 mg QD.
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.
Exclusion criteria
1. Concomitant use of medication(s) which could influence the pharmacokinetics of pazopanib, 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 wouldimpair 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6137 |
| NTR-old | NTR6275 |
| Other | 2016-005252-21 (EudraCT) : N17PSI (NKI-AVL study code) |