To determine the influence of prednisone on docetaxel pharmacokinetics compared to docetaxel alone
ID
Bron
Verkorte titel
Aandoening
patients with metastatic castration-resistant and hormone-sensitive prostate cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients.
Achtergrond van het onderzoek
In this study we try to determine the influence of prednisone on the exposure of docetaxel vs docetaxel alone in men with metastatic castration-resistant or hormone-sensitive prostate cancer.
Doel van het onderzoek
To determine the influence of prednisone on docetaxel pharmacokinetics compared to docetaxel alone
Onderzoeksopzet
During cycle 3 and cycle 6 of docetaxel treatment
Onderzoeksproduct en/of interventie
docetaxel vs docetaxel and prednisone
Publiek
Bodine Belderbos
Rotterdam 3015CE
The Netherlands
06-41647236
b.belderbos@erasmusmc.nl
Wetenschappelijk
Bodine Belderbos
Rotterdam 3015CE
The Netherlands
06-41647236
b.belderbos@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1.Histologicallly or cytologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentitation or small cell features.
2. Continued androgen deprivation therapy either by gonadotropin releasing hormone (GnRH) analogues or orchiedectomy
3. Age ≥18 years
4. Metastatic disease progression
5. ECOG performance status 0-1
6. Written informed consent according to ICH-GCP
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Impossibility or unwillingness to take oral drugs
2. Serious concurrent illness or medical unstable condition requiring treatment
3. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
4. Known hypersensitivity to studiemedication
5. Use of medication or dietary supplements known to induce CYP3A
6. Any active systemic or local bacterial, viral, fungal - or yeast infection.
7. Abnormal renal function defined as (within 21 days before randomization): Serum creatinin > 1.5 x upper limit of normal (ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min will be excluded.
8. Abnormal liver functions consisting of any of the following (within 21 days before randomization):
o Total bilirubin ≥ 1 x ULN (except for patients with documented Gilbert’s disease)
o alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) ≥ 2.5 x ULN. (in case of liver metastases >5 x ULN)
o Alkaline phosphatase (AF) > 5 x ULN (in case of bone metastases > 10 x ULN)
9. Abnormal hematological blood counts consisting of any of the following (within 21 days before randomization):
o Absolute neutrophil count ≤ 1.5 x 109/L
o Platelets ≤ 100 x 109/L
10. Geographical, psychological or other non-medical conditions interfering with follow-up
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5857 |
NTR-old | NTR6037 |
Ander register | METC Erasmus MC : MEC 16-365 |