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Optimizing Abiraterone Therapy (OPTIMUM)

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: NCT02426333
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Radboud University Medical Center

Brief Summary:
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.

Condition or disease Intervention/treatment
Metastatic Castration Resistant Prostate Cancer Other: Abiraterone Acetate

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Abiraterone Acetate
abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study
Other: Abiraterone Acetate
Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)




Primary Outcome Measures :
  1. abiraterone AUC [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. biomarkers: relation between biomarkers and treatment response [ Time Frame: 6 months ]
    relation between biomarkers and treatment response

  2. biomarker reduction [ Time Frame: 6 months ]
    To explore the if reduction in biomarkers is related to treatment response after three and six months


Biospecimen Retention:   Samples With DNA
Blood samples for abiraterone concentrations and also blood samples to assess biomarkers (some contain DNA)


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
Male patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
Criteria

Inclusion Criteria:

  • Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
  • Age ≥18 years
  • Feasible to collect blood samples from
  • Life expectancy of > 6 months
  • Measurable disease
  • Able and willing to give written informed consent prior to screening and enrollment

Exclusion Criteria:

  • other anticancer therapies
  • potent CYP3A4 inducers
  • herbal medicine that could interfere with abiraterone exposure

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): NCT02426333


Locations
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Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Radboud UMC
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
Janssen-Cilag Ltd.
Investigators
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Principal Investigator: Nielka van Erp, PharmD, PhD Radboud University Medical Center
Principal Investigator: Jack Schalken, PhD Radboud University Medical Center
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02426333    
Other Study ID Numbers: UMCN AKF-14.07
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors