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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471469
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Radboud University

Brief 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.


Condition or disease Intervention/treatment
Metastatic Castration Resistant Prostate Cancer Drug: Enzalutamide, 160mg, 40 mg soft capsules, once daily

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Enzalutamide, 160mg, 40 mg soft capsules, once daily
    Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label


Primary Outcome Measures :
  1. Relation between biomarker response and therapeutic response [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Relation between drug exposure, biomarker and therapeutic response [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
chemotherapy naive patients with metastatic CRPC
Criteria

Inclusion Criteria:

  • Male patients with chemotherapy naive metastatic castration resistant prostate cancer*
  • Age at least 18 years
  • Patients from who it is possible to collect blood samples
  • Patient who are able and willing to give written informed consent prior to screening and enrollment
  • Life expectancy of > 6 months
  • Measurable disease *definition of CRPC according to EAU guidelines 2014

Exclusion Criteria:

  • None The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict exclusion criteria will be used in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471469


Locations
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Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
Radboud UMC
Nijmegen, Netherlands, 6500HB
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Astellas Pharma Europe B.V.
Investigators
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Principal Investigator: Nielka van Erp, PharmD, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02471469    
Other Study ID Numbers: AKF UMCN 14.17
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases