Status:
UNKNOWN
Determining the Clinical Relevance of the Interaction Between Enzalutamide and the Opioid Morphine and the DOAC Edoxaban
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Drug-drug Interaction
Eligibility:
MALE
18+ years
Brief Summary
Enzalutamide is one of the oncolytic drugs that showed efficacy and safety in most of the features of prostate cancer. Approximately 17% of the patients treated with enzalutamide need pain control. Ne...
Eligibility Criteria
Inclusion
- Patients with prostate cancer who will start treatment with enzalutamide within label
- Patients who are on treatment with opioids and/or therapeutic anticoagulation, that are treated with or willing and able to switch to morphine (2 dd extended release equivalent dose) and/or edoxaban (30mg or 60mg OD, according to the label)
- Age at least 18 years
- Patients 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
Exclusion
- Patients who are co-treated with drugs that could interfere with the metabolism of enzalutamide, edoxaban and/or morphine
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05339672
Start Date
July 1 2024
End Date
August 31 2024
Last Update
October 27 2022
Active Locations (3)
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1
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
2
Radboudumc
Nijmegen, Netherlands
3
Franciscus Gasthuis en Vlietland hospital
Rotterdam, Netherlands