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Increasing the amount of pazopanib in the blood by splitting intake moments


- candidate number26714
- NTR NumberNTR6275
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2017
- Secondary IDsN17PSI (NKI-AVL study code) 2016-005252-21 (EudraCT)
- Public TitleIncreasing the amount of pazopanib in the blood by splitting intake moments
- Scientific TitleIncreasing pazopanib exposure by splitting intake moments
- ACRONYMN17PSI (pazopanib split intake)
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedRenal cell carcinoma, Soft tissue sarcoma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate31-dec-2017
- Target number of participants10
- InterventionsThe intervention of the study consists of splitting the intake moments of pazopanib for one week into 400 mg BID instead of 800 mg QD.
- Primary outcomeThe 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 outcomeThe 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
- TimepointsNA
- Trial web siteNA
- statusplanned
- CONTACT FOR PUBLIC QUERIES Steffie Groenland
- CONTACT for SCIENTIFIC QUERIES Steffie Groenland
- Sponsor/Initiator Antoni van Leeuwenhoek
- Funding
(Source(s) of Monetary or Material Support)
Antoni van Leeuwenhoek
- PublicationsNA
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD16-feb-2017 - 3-mei-2017


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