Patients for whom palbociclib is standard of care (breast cancer)
Conditions
Interventions
Trade Name: Ibrance
Pharmaceutical Form: Capsule
Trade Name: Erythromycin
Pharmaceutical Form: Tablet
Sponsors
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
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; • Legal incapacity; • QT duration corrected for heart rate > 450 ms or > 480 ms for subjects with bundle branch block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactSteffie Groenland
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Outcome results
None listed