Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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This randomized pilot phase I trial studies the side effects of dietary fat levels and abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone acetate.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To assess the dietary effects of a low fat and high fat diet at a low abiraterone acetate dose (250 mg) on drug levels compared to standard dose administered in a fasting condition.

SECONDARY OBJECTIVES:

I. To potentially guide decisions in the future to use low dose abiraterone in a fed state and decrease overall cost.

II. To evaluate the potential relationship between esterase activity and abiraterone metabolism in an exploratory analysis.

III. To determine the feasibility of using patient-collected dried blood spot (DBS) samples for pharmacokinetic monitoring.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive standard dose abiraterone acetate orally (PO) once daily (QD) (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.

ARM II: Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.

Conditions

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Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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abiraterone acetate

Given PO

Intervention Type DRUG

dietary intervention

Receive low fat breakfast

Intervention Type DIETARY_SUPPLEMENT

dietary intervention

Receive high fat breakfast

Intervention Type DIETARY_SUPPLEMENT

pharmacological study

Correlative studies

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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CB7630 Zytiga Dietary Modification intervention, dietary Dietary Modification intervention, dietary pharmacological studies

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed adenocarcinoma of the prostate
* About to initiate or currently being treated with abiraterone acetate 1000 mg orally once daily
* Clinically able to receive abiraterone acetate in the opinion of the investigator in accordance with standard prescribing practices
* Ability to consume a low fat and high fat diet
* Expected duration of continuous abiraterone therapy \> 8 weeks
* Signed and dated informed consent

Exclusion Criteria

* Patients taking medications that strongly inhibit or induce cytochrome P450 (CYP)3A4 within 28 days prior to the start of the study will be excluded

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No