Clinical Trials Directory

Trials / Completed

CompletedNCT02471469

Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response

Personalizing Enzalutamide Therapy by Understanding the Relation Between the Decrease in the Expression Profile of a Panel of Preselected microRNAs, Tumor Related mRNAs and Treatment Response in Chemotherapy Naive Patients With mCRPC

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Radboud University Medical Center · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy. Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.

Conditions

Interventions

TypeNameDescription
DRUGEnzalutamide, 160mg, 40 mg soft capsules, once dailyExclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label

Timeline

Start date
2015-10-01
Primary completion
2019-02-13
Completion
2019-08-01
First posted
2015-06-15
Last updated
2020-10-19

Locations

3 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02471469. Inclusion in this directory is not an endorsement.