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Adenocarcinoma of the ProstatePhase 1NCT01913015

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

A Phase 1 study testing abiraterone acetate, dietary intervention and pharmacological study in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
abiraterone acetate, dietary intervention and pharmacological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jul 2013to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
abiraterone acetate, dietary intervention, pharmacological study, questionnaire administration, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abiraterone acetateDrug

    Also called CB7630, Zytiga

    Given PO

  • dietary interventionDietary supplement

    Also called Dietary Modification, intervention, dietary

    Receive low fat breakfast

  • dietary interventionDietary supplement

    Also called Dietary Modification, intervention, dietary

    Receive high fat breakfast

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • questionnaire administrationOther

    Ancillary studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01913015
Study groupRoleWhat they receive
Arm I (abiraterone acetate, low then high fat breakfast)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
Receives: Drug: abiraterone acetate; Dietary Supplement: dietary intervention; Other: pharmacological study; Other: questionnaire administration; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 hours (day 1)

Secondary outcomes (3)

  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.

    Measured: Day 3

  2. 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.

    Measured: Up to day 14

  3. 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.

    Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJun 2014

Why it stopped: After enrollment of the first 3 subjects, an interim assessment was conducted. Comparing DBS sampling to plasma PK levels yielded unconvincing results.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01913015
Sponsor's protocol ID
9130
Other IDs
NCI-2013-01223, P30CA069533
Status last verified
Apr 2017
First submitted
29 Jul 2013
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing abiraterone acetate, dietary intervention and pharmacological study in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: After enrollment of the first 3 subjects, an interim assessment was conducted. Comparing DBS sampling to plasma PK levels yielded unconvincing results.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve (AUC)0-24 measurement (time frame: Up to 24 hours (day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01913015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.

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