A Phase 1 interventional study of abiraterone acetate and dietary intervention in Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, sponsored by OHSU Knight Cancer Institute. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by OHSU Knight Cancer Institute · Phase 1, Interventional, and Treatment
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.
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 3 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard dose abiraterone acetate PO 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.
Drug: abiraterone acetate · Dietary Supplement: dietary intervention · Other: pharmacological study · Other: questionnaire administration · Other: laboratory biomarker analysis
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.
Drug: abiraterone acetate · Dietary Supplement: dietary intervention · Other: pharmacological study · Other: questionnaire administration · Other: laboratory biomarker analysis
Given PO
Also known as: CB7630, Zytiga
Receive low fat breakfast
Also known as: Dietary Modification, intervention, dietary
Receive high fat breakfast
Also known as: Dietary Modification, intervention, dietary
Correlative studies
Also known as: pharmacological studies
Ancillary studies
Correlative studies
Area under the curve (AUC)0-24 measurement
The cross-over difference (log\[AUC0-24(low fat)\] - log\[AUC0-24(high fat)\]) of each patient will be computed and graphically illustrated. The cross-over difference will be estimated and reported with 95% confidence interval. Hills-Armitage approach will be used to adjust for the period effect for the estimation. In addition, a bioequivalence range will be computed for the log(AUC0-24\[1000 mg with fasting food\]), allowing for 20% differences in each side.
Time frame: Up to 24 hours (day 1)
Accuracy of patient-collected DBS sampling technique
The first three patients enrolled will have duplicate venous blood samples obtained in clinic 2 hours post-dose for in vivo confirmation of the DBS methodology.
Time frame: Day 3
Patient adherence to pre-defined sampling schedule
Patients will document the date/time of drug administration and the date/time of sample collection using a drug and DBS sample diary. Deviations greater than 10% of the shorter of the two time intervals surrounding the pre-defined time point will be considered non-adherent. Adherence rates will be compared for different time points.
Time frame: Up to day 14
Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method
Paired t-test will be conducted to compare the DBC (or transformed DBC) for the evaluation of carry-over effect.
Time frame: Day 14
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute