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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01913015
First received: July 29, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: abiraterone acetate
Dietary Supplement: dietary intervention
Other: pharmacological study
Other: questionnaire administration
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Area under the curve (AUC)0-24 measurement [ Time Frame: Up to 24 hours (day 1) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Accuracy of patient-collected DBS sampling technique [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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.

  • Patient adherence to pre-defined sampling schedule [ Time Frame: Up to day 14 ] [ Designated as safety issue: No ]
    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.

  • Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Paired t-test will be conducted to compare the DBC (or transformed DBC) for the evaluation of carry-over effect.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (abiraterone acetate, low then high fat breakfast)
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
Given PO
Other Names:
  • CB7630
  • Zytiga
Dietary Supplement: dietary intervention
Receive low fat breakfast
Other Names:
  • Dietary Modification
  • intervention, dietary
Dietary Supplement: dietary intervention
Receive high fat breakfast
Other Names:
  • Dietary Modification
  • intervention, dietary
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (abiraterone acetate, high then low fat breakfast)
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
Given PO
Other Names:
  • CB7630
  • Zytiga
Dietary Supplement: dietary intervention
Receive low fat breakfast
Other Names:
  • Dietary Modification
  • intervention, dietary
Dietary Supplement: dietary intervention
Receive high fat breakfast
Other Names:
  • Dietary Modification
  • intervention, dietary
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913015

Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Timothy Newby    503-494-3456    newbyt@ohsu.edu   
Principal Investigator: Tomasz M. Beer         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Tomasz Beer OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01913015     History of Changes
Other Study ID Numbers: 9130, NCI-2013-01223, P30CA069533
Study First Received: July 29, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014