prostate cancer prostate carcinoma
Conditions
Interventions
Cabazitaxel 25 mg/m2 three weekly intravenously, conform standard of care
Enzalutamide 160 mg daily from day 7-9 until day 42 van de studie
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age * 18 years Histological or cytological confirmed diagnosis of mCRPC ECOG Performance Status * 1 Written informed consent according to ICH-GCP prior to screening evaluations Indication for cabazitaxel treatmentPatients who are, as per local protocol, eligible for treatment with standard of care cabazitaxel. NB: patients are allowed to have had earlier cabazitaxel cycles Adequate organ function as defined by: a.Total bilirubin * 1.5 x ULN (except in case of documented Gilbert*s disease) b.ASAT * 2.5 x ULN (or * 5 x ULN if liver metastases are present) c.ALAT * 2.5 x ULN (or * 5 x ULN if liver metastases are present) d.Serum creatinin * 1.5 x ULN
Exclusion criteria
Exclusion criteria: Evidence of central nervous system disease History of seizure or any condition predisposing to seizure Use of concomitant medication predisposing to seizure Use of (over the counter) medication or (herbal) supplements which can interact with either cabazitaxel or enzalutamide, e.g. by induction or inhibition of CYP3A4, CYP2C9 and CYP2C19 (see appendix B and C) Unable or unwilling to abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study Previous use of enzalutamide during the last 6 weeks prior to cabazitaxel treatment Contraindications for use of enzalutamide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cabazitaxel pharmacokinetics (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity Cabazitaxel pharmacokinetics (the maximum concentration (Cmax), steady-state volume of distribution (Vss) and half-life (t*)). | — |
Countries
Netherlands
Outcome results
None listed