breast cancer mammary carcinoma
Conditions
Interventions
Palbociclib will be administered concomitant with erythromycin during 7 days of
the study.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed