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Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01543776
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Stage IV Prostate Cancer Drug: abiraterone acetate Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare the pharmacodynamic effect of reduced dose (250mg daily) abiraterone acetate in the prandial state (250mg-Fed) to the full, standard 1000mg daily dose in the fasting state (1000mg-Fasting) as assessed by change in serum prostate-specific antigen (PSA).

SECONDARY OBJECTIVES:

I. To evaluate the effect of prandial states on plasma levels and the intra-patient pharmacokinetic variability of abiraterone acetate.

II. To evaluate the safety profile of reduced dose abiraterone acetate taken in the prandial state.

III. To evaluate the pharmacodynamic effect of reduced dose abiraterone acetate in the prandial state as assessed by reduction in the extra-gonadal androgen dihydroepiadrosterone sulfate (DHEA-S) and dihydroepiandrostenedione (DHEA).

IV. To evaluate the effect of prandial state on time to disease progression (Working group criteria).

OUTLINE: Patients are randomized to one of two treatment arms.

ARM I: Patients receive abiraterone acetate orally (PO) daily first thing in morning after an overnight fast of at least 8 hours.

ARM II: Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Both arms will also be treated with prednisone 5mg twice daily.

After completion of study treatment, patients are followed up within 30 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Pilot Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer
Study Start Date : January 2012
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I (fasting)
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
 Drug: abiraterone acetate
Given PO
Other Names:
  • CB7630
  • Zytiga
Experimental: Arm II (fed)
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
 Drug: abiraterone acetate
Given PO
Other Names:
  • CB7630
  • Zytiga


Outcome Measures
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Primary Outcome Measures :
  1. Change in PSA Level [ Time Frame: From baseline to 12 weeks ]
    Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Assessed up to 3 years ]
    Time to PSA progression (25% increase from baseline), radiographic progression, or death.

  2. Adrenal Androgen Production (DHEA-S) [ Time Frame: Cycle 4 (4 months) ]
    Extragonadal serum adrogen

  3. Number of Participants With Adverse Events (AEs) [ Time Frame: Assessed up to 1 year ]
    Patients with grade 3 or higher AE (CTCAE Version 4.03)

  4. Peak Plasma Concentration of Abiraterone [ Time Frame: Up to 4 months ]
    Analyzed on a log scale due to skewness of distribution


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed prostate cancer with progressive disease defined as either:

    • 2 or more new lesions on bone scan or
    • Progressive disease on computed tomography (CT)/magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria or
    • Rising prostate-specific antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart
  • Evidence of castration resistance defined as disease progression despite a testosterone level < 50 ng/dL (or surgical castration)

  • Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required

    • Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug
    • Denosumab or zoledronic acid are allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Total bilirubin =< 1.5 x the upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drug

  • Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug is excluded with the following exceptions:

    • Conventional multivitamin supplements
    • Selenium
    • Lycopene
    • Soy supplements
  • Inability to swallow capsules or known gastrointestinal malabsorption
  • History of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollment
  • Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings < 160/100)
  • Serum potassium (K)+ < 3.5 mmoL/L on more than one reading within the screening period
  • Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
  • Active psychiatric illness/social situations that would limit compliance with protocol requirements
  • New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
  • Concurrent therapy with strong inhibitors or inducers of Cytochrome P450 (CYP)3A4 due to concerning possible drug-drug interactions with abiraterone
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): NCT01543776


Locations
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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
North Shore University Health System
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60430
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Russell Szmulewitz University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Study Protocol and Statistical Analysis Plan  [PDF] June 18, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01543776    
Other Study ID Numbers: 11-0709
NCI-2012-00116 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 5, 2012    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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