Changes in the amount of palbociclib in the blood when administered concomitant with erythromyci
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Patients for whom palbociclib is standard of care (breast cancer)
- Registration Number
- EUCTR2018-004032-29-NL
- Lead Sponsor
- etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11
•Histological or cytological proof of cancer for which palbociclib is considered standard care;
•Age = 18 years;
•Able and willing to give written informed consent;
•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.
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 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
•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;
•Legal incapacity;
•QT duration corrected for heart rate > 450 ms or > 480 ms for subjects with bundle branch block.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.;Secondary Objective: The secondary objective of this trial is to compare the incidence and severity of adverse events with (a week) and without co-administration of the moderate CYP3A4 inhibitor erythromycin, according to CTC-AE v5.0;Primary end point(s): The effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.;Timepoint(s) of evaluation of this end point: At Day 7 and Day 21 of the trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The incidence and severity of adverse events with (a week) and without co-administration of the moderate CYP3A4 inhibitor erythromycin, according to CTC-AE v5.0;Timepoint(s) of evaluation of this end point: At Day 7 and Day 21 of the trial