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

NCT01913015 | Terminated Phase 1 DMC

• 3 other identifiers: 9130NCI-2013-01223P30CA069533
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Accuracy of patient-collected DBS sampling technique

  Day 3

• Patient adherence to pre-defined sampling schedule

  Up to day 14

• Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method

  Day 14

Study Arms (2)

Arm I (abiraterone acetate, low then high fat breakfast)

EXPERIMENTAL

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

Arm II (abiraterone acetate, high then low fat breakfast)

EXPERIMENTAL

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

Interventions

abiraterone acetate DRUG

Given PO

Also known as: CB7630, Zytiga

Arm I (abiraterone acetate, low then high fat breakfast); Arm II (abiraterone acetate, high then low fat breakfast)

dietary intervention DIETARY_SUPPLEMENT

Receive low fat breakfast

Also known as: Dietary Modification, intervention, dietary

Arm I (abiraterone acetate, low then high fat breakfast); Arm II (abiraterone acetate, high then low fat breakfast)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (abiraterone acetate, low then high fat breakfast); Arm II (abiraterone acetate, high then low fat breakfast)

questionnaire administration OTHER

Ancillary studies

Arm I (abiraterone acetate, low then high fat breakfast); Arm II (abiraterone acetate, high then low fat breakfast)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (abiraterone acetate, low then high fat breakfast); Arm II (abiraterone acetate, high then low fat breakfast)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nutrition Therapy; Therapeutics

Study Officials

• Tomasz Beer

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (1)