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NCT02471469 Clinical Trial

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

Metastatic Castration Resistant Prostate Cancer Clinical Trial

— ILUMINATE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02471469
Other study ID # AKF UMCN 14.17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date August 1, 2019

Study information
Verified date September 2019
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 1, 2019
Est. primary completion date February 13, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Jeroen Bosch Ziekenhuis Den Bosch
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen
Netherlands Radboud UMC Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Astellas Pharma Europe B.V.

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Benoist GE, van Oort IM, Boerrigter E, Verhaegh GW, van Hooij O, Groen L, Smit F, de Mol P, Hamberg P, Dezentjé VO, Mehra N, Gerritsen W, Somford DM, van Erp NPH, Schalken JA. Prognostic Value of Novel Liquid Biomarkers in Patients with Metastatic Castrat — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Relation between biomarker response and therapeutic response 6 months
Secondary Relation between drug exposure, biomarker and therapeutic response 6 months
See also
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Terminated NCT02441517 - A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment Phase 4
Active, not recruiting NCT03454750 - Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) Phase 2
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Terminated NCT03177187 - Combination Study of AZD5069 and Enzalutamide. Phase 1/Phase 2
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Completed NCT02991911 - A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer Phase 1
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