Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib
- Conditions
- breast cancermammary carcinoma10006291
- Registration Number
- NL-OMON45801
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
• Histological or cytological proof of cancer for which palbociclib is considered standard care;
• Age >= 18 years;
• WHO performance status of 0, 1 or 2;
• Adequate organ function per judgement of the treating physician;
• Able and willing to undergo blood sampling for PK analysis.
• Concomitant use of medication(s) which could influence the pharmacokinetics of palbociclib within 14 days or five half-lives of the drug (whichever is shorter) before start of the study, consisting of (but not limited to) CYP3A4-inhibitors/inductors
• Women who are pregnant or breast feeding;
• Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
• Palbociclib related side effects that would require a dose reduction per judgement of the treating physician;
• QT duration corrected for heart rate > 450 ms or > 480 ms for subjects with bundle branch block.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this trial is to study the effect of the moderate<br /><br>CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured<br /><br>as AUC0-24h, Cmax and Cmin.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this trial is to compare the incidence and severity<br /><br>of adverse events with (a week) and without co-administration of the moderate<br /><br>CYP3A4 inhibitor erythromycin, according to CTC-AE v5.0.</p><br>