2024-517646-34-00CompletedPhase 4
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Nov 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 3 Oct 2024
- Start date
- 1 Feb 2023
- Lead sponsor
- Radboud universitair medisch centrum Stichting
- Diseases
- Prostate cancer
- EU CT number
- 2024-517646-34-00
- EudraCT number
- 2022-001410-20
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 40
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Deventer Ziekenhuis | Deventer | Netherlands | Completed |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands | Completed |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Completed |
| Sint Franciscus Vlietland Groep Stichting | Rotterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.