Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer
Key facts
- Where
- Deventer, Nijmegen és Rotterdam, HollandiaSee the 4 sites
- Phase
- 4. fázis
Where in Hollandia
- Deventer ZiekenhuisDeventer, HollandiaNo longer taking part
- Canisius Wilhelmina ZiekenhuisNijmegen, HollandiaNo longer taking part
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaNo longer taking part
- Sint Franciscus Vlietland Groep StichtingRotterdam, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud universitair medisch centrum Stichting
- Trial code
- EU 2024-517646-34-00
- Record updated
- 2024. november 15.
- Original description
To determine the change in edoxaban and M4 exposure (AUC0-24hr) with or without enzalutamide - To determine the change in morphine and morphine-6- glucuronide exposure (AUC0-12hr) with or without enzalutamideRead full original descriptionShow less
To determine the change in edoxaban and M4 exposure (AUC0-24hr) with or without enzalutamide - To determine the change in morphine and morphine-6- glucuronide exposure (AUC0-12hr) with or without enzalutamide
Inclusion: Patient with prostate cancer - Patients who will start treatment with enzalutamide within label or are on treatment with enzalutamide AND are on treatment with edoxaban (30mg or 60mg OD, according to the label) (edoxaban arm 1) OR are on treatment with morphine IR or other opioids IR and willing and able to switch to morphine IR or not treated with opioids and willing and able to receive morphine (a single-dose of 10 mg immediate-release (group 1)) or are on treatment with morphine XR or other opioids XR and able to switch to morphine XR BID (group 2)) (morphine arm 3) OR - Patients that are on treatment with edoxaban (30 or 60mg OD, according to the label) (edoxaban arm 2) OR are on treatment with morphine IR or other opioids IR and willing and able to switch to morphine IR or not treated with opioids and willing and able to receive morphine (a singledose of 10 mg immediate-release (group 1) or are on treatment with morphine XR or other opioids XR and able to switch to morphine XR BID (group 2)) (morphine arm 4) - Age at least 18 years - Patient who are able and willing to give written informed consent prior to screening - Patients from whom it is possible to collect blood samples - Life expectancy of > 3 months - Stable renal function and renal clearance > 50ml/min.