Since cabazitaxel will increasingly substitute docetaxel in the setting of mCRPC , it is important to investigate whether cabazitaxel PK is significantly and clinically relevantly influenced by enzalutamide treatment, especially after more than 3…
ID
Bron
Verkorte titel
Aandoening
Metastatic castrate-resistant prostate cancer (mCRPC)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine the influence of enzalutamide on cabazitaxel AUC compared to cabazitaxel alone in mCRPC patients.
Achtergrond van het onderzoek
Since cabazitaxel will increasingly substitute docetaxel in the setting of mCRPC , it is important to investigate whether cabazitaxel PK is significantly and clinically relevantly influenced by enzalutamide treatment, especially after more than 3 weeks of concomitant use. Cabazitaxel is also extensively metabolized by CYP3A4 and it is expected that this drug is prone to drug-drug interactions with CYP3A inducing co-medication (like enzalutamide). In this study we therefore investigate the pharmacokinetics (PK) and safety of cabazitaxel concomitantly used with enzalutamide in men with mCRPC.
Doel van het onderzoek
Since cabazitaxel will increasingly substitute docetaxel in the setting of mCRPC , it is important to investigate whether cabazitaxel PK is significantly and clinically relevantly influenced by enzalutamide treatment, especially after more than 3 weeks of concomitant use. Cabazitaxel is also extensively metabolized by CYP3A4 and it is expected that this drug is prone to drug-drug interactions with CYP3A inducing co-medication (like enzalutamide). In this study we therefore investigate the pharmacokinetics (PK) and safety of cabazitaxel concomitantly used with enzalutamide in men with mCRPC.
Onderzoeksopzet
n.a.
Onderzoeksproduct en/of interventie
Cabazitaxel will be used as standard of care treatment. Enzalutamide is also registered for treatment of mCRPC, but in this study it will be administered solely for investigational purpose.
Algemeen / deelnemers
Ron
Mathijssen
Wetenschappers
Ron
Mathijssen
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age: >=18 years
2. Histological or cytological confirmed diagnosis of mCRPC
3. ECOG Performance Status ¡Ü 1
4. Written informed consent according to ICH-GCP prior to screening evaluations
5. Patients who are, as per local protocol, eligible for treatment with standard of care cabazitaxel
6. Adequate organ function as defined by:
a. Total bilirubin ¡Ü 1.5 x ULN (except in case of documented Gilbert¡¯s disease)
b. ASAT ¡Ü 2.5 x ULN (or ¡Ü 5 x ULN if liver metastases are present)
c. ALAT ¡Ü 2.5 x ULN (or ¡Ü 5 x ULN if liver metastases are present)
d. Serum creatinin ¡Ü 1.5 x ULN
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Evidence of central nervous system disease
2. History of seizure or any condition predisposing to seizure
3. Use of concomitant medication predisposing to seizure
4. 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
5. Unable or unwilling to abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study
6. Previous use of enzalutamide during the last 6 weeks prior to cabazitaxel treatment
7. Contraindications for use of enzalutamide
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5018 |
| NTR-old | NTR5164 |
| CCMO | NL51749.078.14 |
| OMON | NL-OMON41753 |