Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT01543776 |
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Recruitment Status :
Completed
First Posted : March 5, 2012
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Castration-resistant Prostate Cancer Stage IV Prostate Cancer | Drug: abiraterone acetate | Phase 2 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I (fasting)
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
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Drug: abiraterone acetate
Given PO
Other Names:
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Experimental: Arm II (fed)
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
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Drug: abiraterone acetate
Given PO
Other Names:
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- 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.
- Progression-free Survival (PFS) [ Time Frame: Assessed up to 3 years ]Time to PSA progression (25% increase from baseline), radiographic progression, or death.
- Adrenal Androgen Production (DHEA-S) [ Time Frame: Cycle 4 (4 months) ]Extragonadal serum adrogen
- 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)
- Peak Plasma Concentration of Abiraterone [ Time Frame: Up to 4 months ]Analyzed on a log scale due to skewness of distribution
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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)
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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
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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
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
| 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 | |
| Principal Investigator: | Russell Szmulewitz | University of Chicago |
Documents provided by University of Chicago:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male 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 |