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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

An Open-Label, Phase I, Randomized Pharmacokinetic Study of Dietary Effects on Abiraterone Acetate Drug Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (DEAL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01913015
• Other study ID #: 9130
• Secondary ID: NCI-2013-01223P3
• Status: Terminated
• Phase: Phase 1
• First received: July 29, 2013
• Last updated: April 26, 2017
• Start date: July 2013

Study information

• Verified date: April 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Intervention

Drug:
• abiraterone acetate
Given PO

Dietary Supplement:
• dietary intervention
Receive low fat breakfast
• dietary intervention
Receive high fat breakfast

Other:
• pharmacological study
Correlative studies
• questionnaire administration
Ancillary studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 hours (day 1)
Secondary	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.	Day 3
Secondary	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.	Up to day 14
Secondary	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.	Day 14