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.
ID
Bron
Verkorte titel
Aandoening
Patients for who treatment with pazopanib is considered standard care (renal cell carcinoma and soft-tissue sarcoma).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
NA
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6137 |
| NTR-old | NTR6275 |
| Ander register | 2016-005252-21 (EudraCT) : N17PSI (NKI-AVL study code) |