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

This study has been terminated.
(After enrollment of the first 3 subjects, an interim assessment was conducted. Comparing DBS sampling to plasma PK levels yielded unconvincing results.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01913015
First Posted: July 31, 2013
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute
  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
Intervention Model: Crossover Assignment
Masking: None (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 Tom Beer, OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Area under the curve (AUC)0-24 measurement [ Time Frame: Up to 24 hours (day 1) ]
    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 ]
    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 ]
    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 ]
    Paired t-test will be conducted to compare the DBC (or transformed DBC) for the evaluation of carry-over effect.


Enrollment: 3
Study Start Date: July 2013
Primary Completion Date: June 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913015


Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Tomasz Beer OHSU Knight Cancer Institute
  More Information

Responsible Party: Tom Beer, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01913015     History of Changes
Other Study ID Numbers: 9130
NCI-2013-01223 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2013
First Posted: July 31, 2013
Last Update Posted: April 28, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors