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

NCT02730975 | Completed Phase 1 DMC

• 2 other identifiers: ABIFOOD012012-003226-25
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

pharmacokinetics; food-effect; fat diet; abiraterone acetate

Outcome Measures

Primary Outcomes (3)

• Area under curve (AUC)

  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)

  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 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 Outcomes (5)

• PSA (Prostate Specific Antigen) levels

  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

  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

  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

  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

  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

Study Arms (3)

AA Reduced dose-normal diet (A)

EXPERIMENTAL

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)

AA reduced dose-fat diet (B)

EXPERIMENTAL

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)

AA normal dose-fasting conditions (C)

ACTIVE COMPARATOR

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)

Interventions

AA Reduced dose-normal diet (A) DRUG

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.

Also known as: Abiraterone acetate 250 mg normal diet

AA Reduced dose-normal diet (A)

AA reduced dose-fat diet (B) DRUG

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.

Also known as: Abiraterone acetate 250 mg fat- diet

AA reduced dose-fat diet (B)

AA normal dose-fasting conditions (C) DRUG

Cycles of 28 days length of AA at approved doses (1000 mg) administered in fasting conditions.

Also known as: Abiraterone acetate 1000 mg fasting conditions

AA normal dose-fasting conditions (C)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ignacio Durán Martínez, MD-PhD

  Hospital Universitario Virgen del Rocío, Seville, Spain

  STUDY DIRECTOR

• Clara Rosso Fernández, MD-PhD

  Hospital Universitario Virgen del Rocío, Seville, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: April 7, 2016
• Study Start: May 12, 2014
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

ES (1)