We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02730975
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: AA Reduced dose-normal diet (A) Drug: AA reduced dose-fat diet (B) Drug: AA normal dose-fasting conditions (C) Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Food-effect Study of Abiraterone Acetate (A.A) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Actual Study Start Date : May 12, 2014
Actual Primary Completion Date : October 10, 2020
Actual Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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 Name: 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 Name: Abiraterone acetate 1000 mg fasting conditions




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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.

  5. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02730975


Locations
Layout table for location information
Spain
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT02730975    
Other Study ID Numbers: ABIFOOD01
2012-003226-25 ( EudraCT Number )
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
pharmacokinetics
food-effect
fat diet
abiraterone acetate
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
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