The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs

NCT03920566 | Unknown

• 1 other identifier: CCR 5039
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine the nature and significance of the theoretical drug interaction between enzalutamide (a drug used to treat prostate cancer) and the direct-acting oral anticoagulant drugs (DOACs). This will be done in two ways: a laboratory study which will take place at the University of Brighton, and a clinical study in which patients will be identified who are currently taking DOACs and are due to start treatment with enzalutamide. The activity of the DOAC will be monitored using anti-Xa levels before and after commencing treatment with enzalutamide.

Conditions

Drug Interaction

Keywords

Enzalutamide; Anticoagulant Drugs; P-glycoprotein

Outcome Measures

Primary Outcomes (3)

• Anti-Xa level

  Difference between anti-Xa levels taken at two time points (baseline and 4-weeks after commencing enzalutamide)

  time 0 and time 4 weeks

• Efflux ratio (with enzalutamide)

  Difference in efflux ratio for edoxaban/ rivaroxaban / apixaban in the absence/presence of enzalutamide over a range of concentrations

  Each experiment will be conducted over a period of <1 day

• Efflux ratio (with enzalutamide and positive control)

  Difference in efflux ratio for edoxaban/ rivaroxaban / apixaban in the presence of enzalutamide and a positive control (e.g. verapamil, whilst ensuring appropriate statistical power)

  Each experiment will be conducted over a period of <1 day

Secondary Outcomes (3)

• Bleeding

  4 weeks

• Bruising

  4 weeks

• Venous Thromboembolism

  4 weeks

Interventions

Anti-Xa level OTHER

Anti-Xa level taken before commencing enzalutamide and repeated after 4 weeks of treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are currently taking direct-acting oral anticoagulant drugs who are due to start treatment with enzalutamide for the treatment of prostate cancer.

You may qualify if:

• Male patients aged \> 18 years old
• Diagnosis of castrate resistant metastatic prostate cancer
• Due to commence treatment with enzalutamide
• Currently prescribed edoxaban, rivaroxaban or apixaban
• Calculated CrCl (Cockroft \& Gault) \> 30ml/min

You may not qualify if:

• Patients \<18 years old
• Due to stop edoxaban/ rivaroxaban / apixaban during study period (i.e. within 4 weeks of recruitment)
• Currently taking other medicines which induce or inhibit P-gp or increase/reduce the effect of apixaban or rivaroxaban (e.g. verapamil, ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, erythromycin (refer to appendix 1 for complete list)
• Currently taking any herbal/complimentary medicines (other than homeopathic products)
• Calculated CrCl (Cockroft \& Gault) \<30ml/min
• Severe hepatic impairment (Childs-Pugh class C)
• Lacks capacity, including patients with documented dementia (or psychometric marker e.g. Abbreviated Mental Test Score (AMTS) \<7/10) or inability to give informed consent for study participation.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Pharmacy Research UK: collaborator
• University of Brighton: collaborator

Study Officials

• Emma Foreman

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Foreman

CONTACT

0208 6426011; Emma.Foreman@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 19, 2019
• Study Start: May 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share