1/16/2017 Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy - ...
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`Trial record 1 of 1 for: nct01867710
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`Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention
`in Prostate Cancer Prior to Chemotherapy
`
`This study is ongoing, but not recruiting participants.
`
`Sponsor:
`Janssen Pharmaceutica N.V., Belgium
`
`Information provided by (Responsible Party):
`Janssen Pharmaceutica N.V., Belgium
`
`ClinicalTrials.gov Identifier:
`NCT01867710
`
`First received: May 30, 2013
`Last updated: October 5, 2016
`Last verified: October 2016
`History of Changes
`
`Full Text View
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`Tabular View
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`Study Results
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`Disclaimer
`
`How to Read a Study Record
`
` Purpose
`
`The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone
`and dexamethasone in prostate cancer patients. Prednisone will be given at one of three different dose schedules. Dexamethasone will be given
`at one dose schedule. This will include looking at what side effects occur and how often they occur. In addition the impact of the study drug on
`quality of life and pain will be evaluated. The study will also collect data on subsequent treatment of patients after they come off the study drug
`(up to a maximum of 5 years after the study starts). By analyzing blood samples, the study aims to identify if some markers could help to
`understand if the treatment with abiraterone is effective and also help to understand if patients can become resistant.
`
`Condition
`
`Intervention
`
`Prostate Cancer
`
`Drug: Abiraterone Acetate
`Drug: Prednisone 5 mg twice daily
`Drug: Prednisone 5 mg once daily
`Drug: Prednisone 2.5 mg twice daily
`Drug: Dexamethasone 0.5 mg once daily
`
`Phase
`
`Phase 2
`
`Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Endpoint Classification: Safety/Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Open Label
`Primary Purpose: Treatment
`
`Official Title:
`
`A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms
`Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-naïve and Metastatic Castration-resistant Prostate
`Cancer (mCRPC) Patients
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: prostate cancer
`
`MedlinePlus related topics: Cancer Prostate Cancer Steroids
`
`Drug Information available for: Prednisone Abiraterone acetate
`
`Genetic and Rare Diseases Information Center resources: Hyperadrenalism
`
`U.S. FDA Resources
`
`Further study details as provided by Janssen Pharmaceutica N.V., Belgium:
`
`https://clinicaltrials.gov/ct2/show/study/NCT01867710?term=nct01867710&rank=1
`
`Amerigen Exhibit 1187
`Amerigen v. Janssen IPR2016-00286
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`1/16/2017 Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy - ...
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`Primary Outcome Measures:
`
`Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment
`[ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
`
`No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor
`hypertension.
`
`Secondary Outcome Measures:
`
`Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%)
`Decline From Baseline] at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
`
`The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2)
`criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline
`from baseline.
`
`Enrollment:
`Study Start Date:
`Estimated Study Completion Date:
`Primary Completion Date:
`
`164
`July 2013
`July 2018
`April 2015 (Final data collection date for primary outcome measure)
`
`Arms
`
`Assigned Interventions
`
`Drug: Abiraterone Acetate
`
`Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets
`once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the
`tablets.
`Drug: Prednisone 5 mg twice daily
`
`type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken twice daily, the first dose in
`the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or
`early evening, after a meal
`
`Drug: Abiraterone Acetate
`
`Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets
`once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the
`tablets.
`Drug: Prednisone 5 mg once daily
`
`type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning
`after a meal
`
`Drug: Abiraterone Acetate
`
`Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets
`once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the
`tablets.
`Drug: Prednisone 2.5 mg twice daily
`
`type = exact number; unit = mg; number = 2.5; form = tablet; route = oral; taken twice daily, the first dose
`in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon
`or early evening, after a meal
`
`Drug: Abiraterone Acetate
`
`Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets
`once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the
`tablets.
`Drug: Dexamethasone 0.5 mg once daily
`
`type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning
`after breakfast
`
`Experimental: AA + prednisone
`5 mg twice daily
`
`Abiraterone acetate in
`combination with prednisone 5
`mg twice daily
`
`Experimental: AA + prednisone
`5 mg once daily
`
`Abiraterone acetate in
`combination with prednisone 5
`mg once daily dose
`
`Experimental: AA + prednisone
`2.5 mg twice daily
`
`Abiraterone acetate in
`combination with prednisone
`2.5 mg twice daily
`
`Experimental: AA +
`dexamethasone 0.5 mg once
`daily
`
`Abiraterone acetate in
`combination with
`dexamethasone 0.5 mg once
`daily
`
` Show Detailed Description
`
` Eligibility
`
`Ages Eligible for Study:
`
`18 Years and older (Adult, Senior)
`
`https://clinicaltrials.gov/ct2/show/study/NCT01867710?term=nct01867710&rank=1
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`1/16/2017 Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy - ...
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`Genders Eligible for Study: Male
`Accepts Healthy Volunteers: No
`
`Criteria
`
`Inclusion Criteria:
`
`Have a histologically or cytologically confirmed adenocarcinoma of the prostate Have metastatic disease documented by positive bone scan or
`by computed tomography or magnetic resonance imaging Have prostate cancer progression documented by prostate specific antigen according
`to Prostate Cancer Working Group 2 or radiographic progression according to modified RECIST (response evaluation criteria in solid tumors,
`v1.1) criteria Be asymptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered
`asymptomatic Be surgically or medically castrated, with testosterone levels of <50 ng/dL (<2.0 nmol/L). If the subject is being treated with
`luteinizing hormone releasing hormone (LHRH) agonists or antagonists (subjects who have not undergone orchiectomy), this therapy must have
`been initiated at least 4 weeks prior to Day 1, Cycle 1 and must be continued throughout the study.
`
`Exclusion Criteria:
`
`Has a history of pituitary or adrenal dysfunction Has an active infection or other medical condition that would contraindicate corticosteroid use
`Has any chronic medical condition requiring corticosteroid treatment or has received prior corticosteroid treatment for prostate cancer Has a
`pathological finding consistent with small cell carcinoma of the prostate Has a known brain metastasis
`
` Contacts and Locations
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
`study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
`information, see Learn About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT01867710
`
`Locations
`
`Belgium
`
`Aalst, Belgium
`Brussels, Belgium
`Gent, Belgium
`Hasselt, Belgium
`Kortrijk, Belgium
`Leuven, Belgium
`
`Germany
`Hannover, Germany
`Mülheim, Germany
`Nürtingen, Germany
`Tübingen, Germany
`
`Hungary
`
`Budapest, Hungary
`Miskolc, Hungary
`
`United Kingdom
`Birmingham, United Kingdom
`Glasgow, United Kingdom
`London, United Kingdom
`Sutton, United Kingdom
`Whitchurch, United Kingdom
`
`Sponsors and Collaborators
`
`Janssen Pharmaceutica N.V., Belgium
`
` More Information
`
`Janssen Pharmaceutica N.V., Belgium
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT01867710 History of Changes
`Other Study ID Numbers:
`CR100916 2012-004331-23 212082PCR2023
`Study First Received:
`May 30, 2013
`Results First Received:
`April 6, 2016
`Last Updated:
`October 5, 2016
`
`https://clinicaltrials.gov/ct2/show/study/NCT01867710?term=nct01867710&rank=1
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`1/16/2017 Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy - ...
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`Health Authority:
`
`Belgium: Federal Agency for Medicinal Products and Health Products
`Germany: Ethics Commission
`Great Britain: Medicines and Healthcare Products Regulatory Agency
`Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
`Germany: Federal Institute for Drugs and Medical Devices
`Great Britain: Research Ethics Committee
`Hungary: Health Canada
`
`Keywords provided by Janssen Pharmaceutica N.V., Belgium:
`Mineralocorticoid Excess ; Chemotherapy-Naïve; Metastatic Castration-
`Resistant Prostate Cancer; Abiraterone Acetate; Zytiga; Prednisone;
`dexamethasone
`
`Additional relevant MeSH terms:
`Prostatic Neoplasms
`Hyperaldosteronism
`Genital Neoplasms, Male
`Urogenital Neoplasms
`Neoplasms by Site
`Neoplasms
`Genital Diseases, Male
`Prostatic Diseases
`Adrenocortical Hyperfunction
`Adrenal Gland Diseases
`Endocrine System Diseases
`Dexamethasone acetate
`Dexamethasone
`Prednisone
`Dexamethasone 21-phosphate
`
`ClinicalTrials.gov processed this record on January 14, 2017
`
`Abiraterone Acetate
`BB 1101
`Mineralocorticoids
`Anti-Inflammatory Agents
`Antiemetics
`Autonomic Agents
`Peripheral Nervous System Agents
`Physiological Effects of Drugs
`Gastrointestinal Agents
`Glucocorticoids
`Hormones
`Hormones, Hormone Substitutes, and Hormone Antagonists
`Antineoplastic Agents, Hormonal
`Antineoplastic Agents
`Protease Inhibitors
`
`https://clinicaltrials.gov/ct2/show/study/NCT01867710?term=nct01867710&rank=1
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