Status:
TERMINATED
Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 condi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01913015
Start Date
July 1 2013
Last Update
April 28 2017
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239