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

NCT02471469 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-10-19

No results posted yet for this study

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

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

Enzalutamide, 160mg, 40 mg soft capsules, once daily

Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Nielka van Erp, PharmD, PhD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-02-13
Completion
2019-08-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471469 on ClinicalTrials.gov