Pharmacokinetic Food-effect Study of Abiraterone Acetate (AA) in Castration Resistant Prostate Cancer (ABIFOOD01)

January 8, 2021 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Pharmacokinetic Food-effect Study of Abiraterone Acetate (A.A) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

ABIFOOD study is a randomized open-labelled, phase I study to evaluate food effect in the pharmacokinetic parameters of abiraterone acetate (AA) at reduced doses, versus AA in fasting conditions at conventional doses, in castration resistant prostate cancer (mCRPC) patients who have progressed to docetaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Abiraterone acetate (AA) has been approved for the treatment of mCRPC after docetaxel progression at doses of 1.000 mg per day taken in fasting conditions. However, it has been described both the significant food-effect on bioavailability up to 5 to 10 times folder increase depending on the fat content of the diet. These data come from the analysis of a small number of patients in phase I studies conducted in the early stages of drug development and some exploratory study in healthy subjects. There is not prospective randomized study that has analyzed the real impact of the normal diet in the bioavailability of the drug (not a fatty diet like has been used in initial studies).

Given the particular epidemiology of mCRPC (relatively frequent pathology), and taking into account recent data which indicates positive results of AA treatment in patients who had not previously received chemotherapy, a significant use of this drug is anticipated in the uro-oncology community in the coming years.

The precise definition of dose according to the food-effect on bioavailability may be critical not only from a purely medical perspective and / or pharmacological but even for its socioeconomic impact in our health system.

The hypothesis for this study is to prove that AA administered in reduced doses with standard diet presents a suitable pharmacokinetic profile which would achieve therapeutic levels in blood, so that regimens lower than currently approved in association with food can be used in future studies on efficacy.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or with no small cell histology.
  • At least one, but no more than two regimens of cytotoxic chemotherapy for metastatic castration-resistant prostate cancer. At least one regimen must have contained docetaxel.
  • Men 18 years old or more.
  • Criteria for progression according to the recommendations of the Prostate Cancer Working Group.
  • Androgen deprivation present with testosterone levels <50 ng / dl or <2.0 nmol / l).
  • ECOG (Eastern Cooperative Oncology Group) performance status <2.
  • Adequate organ function
  • Accept the use of barrier methods of contraception throughout the study
  • Signature of informed consent to participate in the study consent.

Exclusion Criteria:

  • Inability or unwillingness to swallow tablets.
  • Known brain metastases
  • Significant chronic gastrointestinal disorder with diarrhea as the main symptom (Crohn's disease, ulcerative colitis, malabsorption, or grade ≥ 2 diarrhea of any etiology at baseline).
  • Local prostate surgery or intervention within 30 days prior to the first dose. Further, any clinically relevant sequel to surgery should be resolved before the 1st of cycle 1.
  • Radiotherapy, chemotherapy or immunotherapy within 30 days before or single fraction of palliative radiotherapy within 14 days prior to the administration of the day 1of Cycle 1.
  • Patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, heart failure Class III or IV of the New York Heart Association or cardiac ejection fraction <50%, active or symptomatic viral hepatitis, chronic liver failure, clinically significant adrenal or pituitary dysfunction. (Patients with hypertension controlled with drugs are allowed)
  • Any acute toxicity due to chemotherapy and / or prior radiotherapy has not been resolved to ≤ grade 1 NCI CTCAE (version 4). Alopecia and grade 2 peripheral neuropathy induced by chemotherapy are allowed.
  • Previous treatment with abiraterone acetate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AA Reduced dose-normal diet (A)
Abiraterone acetate at reduced dose of 250 mg po daily in cycles of 28 days administered with a standard breakfast
Drug: AA Reduced dose-normal diet (A)
Cycles of 28 days length of AA at reduced doses (250 mg) administered with a pre-defined normal diet, described with specific caloric and fat content.
Other Names:
  • Abiraterone acetate 250 mg normal diet
Experimental: AA reduced dose-fat diet (B)
Abiraterone acetate at reduced dose of 250 mg po daily in cycles of 28 days administered with a fat breakfast
Drug: AA reduced dose-fat diet (B)
Cycles of 28 days length of AA at reduced doses (250 mg) administered with a pre-defined fat diet, described with specific caloric and fat content.
Other Names:
  • Abiraterone acetate 250 mg fat- diet
Active Comparator: AA normal dose-fasting conditions (C)
Abiraterone acetate at approved dose of 1000 mg po daily in cycles of 28 days administered in fasting conditions
Drug: AA normal dose-fasting conditions (C)
Cycles of 28 days length of AA at approved doses (1000 mg) administered in fasting conditions.
Other Names:
  • Abiraterone acetate 1000 mg fasting conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve (AUC)
Time Frame: 1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose in day 1 of cycle 1 (28 days long) , day 10-14 of cycle 1 and day 1 of cycle 5(28 days long)
Area under curve at time t and infinite, compared with abiraterone acetate administered a standard dose fasting in the times specified: 1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose
1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose in day 1 of cycle 1 (28 days long) , day 10-14 of cycle 1 and day 1 of cycle 5(28 days long)
Peak Plasma Concentration (Cmax)
Time Frame: 1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose in day 1 of cycle 1 (28 days long) , day 10-14 of cycle 1 and day 1 of cycle 5(28 days long)
Peak Plasma Concentration (Cmax) of acetate administered at low doses with meals, compared with abiraterone acetate administered a standard dose fasting in the times specified: 1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose
1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose in day 1 of cycle 1 (28 days long) , day 10-14 of cycle 1 and day 1 of cycle 5(28 days long)
Time to reach peak plasma concentration (Tmax)
Time Frame: 1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose in day 1 of cycle 1 (28 days long) , day 10-14 of cycle 1 and day 1 of cycle 5(28 days long)
Time to reach peak plasma concentration (Tmax) of acetate administered at low doses with meals, compared with abiraterone acetate administered a standard dose fasting in the times specified: 1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose
1, 2, 3, 4, 5, 6, 8, 12, y 24 hours post dose in day 1 of cycle 1 (28 days long) , day 10-14 of cycle 1 and day 1 of cycle 5(28 days long)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA (Prostate Specific Antigen) levels
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Basal PSA levels and monitoring until disease progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Response rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Response rate according to RECIST 1.1
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Pain intensity
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Pain intensity measured by the Brief Pain Inventory-Short Form scale (BPI-SF)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Use of analgesics
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Type of analgesics used for pain treatment.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Total daily dose of analgesics
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Total daily dose of analgesics will be recorded.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Study Director: Ignacio Durán Martínez, MD-PhD, Hospital Universitario Virgen del Rocío, Seville, Spain
  • Principal Investigator: Clara Rosso Fernández, MD-PhD, Hospital Universitario Virgen del Rocío, Seville, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2014

Primary Completion (Actual)

October 10, 2020

Study Completion (Actual)

October 10, 2020

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABIFOOD01
  • 2012-003226-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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