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A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01424930
Recruitment Status : Completed
First Posted : August 29, 2011
Results First Posted : April 30, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Ortho Inc., Canada

Study Description
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Brief Summary:
The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer (mCRPC).

Condition or disease Intervention/treatment Phase
Prostate Neoplasms Prostate Cancer Drug: Abiraterone Drug: Prednisone Phase 2

Detailed Description:
This is a multicenter, open-label study of 24 (up to a total of 28) men to assess the short-term safety of oral abiraterone acetate 1 g and oral prednisone 5 mg twice daily administered in the modified fasted state and after meals of various fat contents. All patients will take daily abiraterone acetate for the first 7 days in the modified fasted state (no food for 2 hours before and 1 hour after the dose). In Cohort 1, up to 6 evaluable patients will take abiraterone acetate daily for 7 days after a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14; or, in Cohort 2, up to 6 evaluable patients will take abiraterone acetate daily for 7 days after a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. All patients will then continue to take abiraterone acetate daily in the modified fasted state starting on Cycle 1 Day 15 until disease progression. Toxicity related to dosing after the low-fat or high-fat meals is defined as Grade 3 or higher AEs of special interest; or Grade 3 or higher serious adverse events (SAEs) that occur during the food safety evaluation period. Cohort 2 may be expanded to a total of 18 evaluable patients if deemed to be safe. Decisions regarding the escalation of cohort or expansion of cohorts will be made by a study evaluation team. Pharmacokinetic evaluation for each cohort will be performed on Cycle 1 Days 7 and 14 at predose and multiple timepoints postdose over 24 hours; Cycle 1 Days 8 and 11 at 2 hours following abiraterone acetate dose administration. Abiraterone acetate, 1 g (four 250-mg tablets) orally (taken by mouth) once daily. Patients may take abiraterone acetate until progression of clinical disease. Prednisone, 5 mg, orally, twice a day.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer
Study Start Date : October 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Abiraterone+prednisone (low-fat meal)
Participants will receive abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
 Drug: Abiraterone
Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.

Drug: Prednisone
Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
Experimental: Abiraterone+prednisone (high-fat meal)
Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
 Drug: Abiraterone
Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.

Drug: Prednisone
Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication [ Time Frame: Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1 ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Abiraterone [ Time Frame: Day 7 and Day 14 ]
    The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone [ Time Frame: Day 7 and Day 14 ]
    The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  3. Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) [ Time Frame: Day 7 and Day 14 ]
    The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the prostate
  • Metastatic disease documented by bone, computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • Surgical or medical castration with testosterone less than 50 ng/dL (< 2.0 nM)
  • Prostate-specific antigen (PSA) or radiographic progression documented by assessments specified in study protocol
  • Platelets >100,000/µl
  • Hemoglobin >=9.0 g/dL
  • Liver function tests (LFTs): Serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN; Eastern Cooperative Oncology Group (ECOG) status score of <=2

Exclusion Criteria:

  • Small cell carcinoma of the prostate
  • Known brain metastasis, chronic liver disease with elevated LFTs
  • Prior cytotoxic chemotherapy for metastatic prostate cancer
  • Treatment of prostate cancer within 30 days of Day 1 Cycle 1 with surgery, radiation, chemotherapy or immunotherapy
  • Use of investigational drug within 30 days of Day 1 Cycle 1 or current enrollment in an investigational drug or device study
  • Recent history of ischemic heart disease, Electrocardiogram (ECG) abnormalities or atrial fibrillation
  • Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
  • Chronic medical condition requiring a higher dose of corticosteroid than prednisone 5 mg twice daily
Contacts and Locations
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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): NCT01424930


Locations
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Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Investigators
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Study Director: Janssen-Ortho, Canada Clinical Trial Janssen-Ortho Inc., Canada
More Information
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Responsible Party: Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT01424930    
Other Study ID Numbers: CR018715
212082PCR2008 ( Other Identifier: Janssen-Ortho, Canada )
First Posted: August 29, 2011    Key Record Dates
Results First Posted: April 30, 2014
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by Janssen-Ortho Inc., Canada:
Metastatic castration-resistant prostate cancer
CRPC
Abiraterone Acetate
Prednisone
Food Safety
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents