Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

NCT01543776 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 11-0709NCI-2012-00116
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 6

Brief Summary

This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.

Conditions

Castration-resistant Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in PSA Level

  Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.

  From baseline to 12 weeks

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  Assessed up to 3 years

• Adrenal Androgen Production (DHEA-S)

  Cycle 4 (4 months)

• Number of Participants With Adverse Events (AEs)

  Assessed up to 1 year

• Peak Plasma Concentration of Abiraterone

  Up to 4 months

Study Arms (2)

Arm I (fasting)

ACTIVE COMPARATOR

Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.

Drug: abiraterone acetate

Arm II (fed)

EXPERIMENTAL

Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.

Drug: abiraterone acetate

Interventions

abiraterone acetate DRUG

Given PO

Also known as: CB7630, Zytiga

Arm I (fasting); Arm II (fed)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed prostate cancer with progressive disease defined as either:
• or more new lesions on bone scan or
• Progressive disease on computed tomography (CT)/magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria or
• Rising prostate-specific antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart
• Evidence of castration resistance defined as disease progression despite a testosterone level \< 50 ng/dL (or surgical castration)
• Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required
• Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug
• Denosumab or zoledronic acid are allowed
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Total bilirubin =\< 1.5 x the upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =\< 10 mg/day) within 4 weeks prior to first dose of study drug
• Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug is excluded with the following exceptions:
• Conventional multivitamin supplements
• Selenium
• Lycopene
• Soy supplements
• Inability to swallow capsules or known gastrointestinal malabsorption
• History of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for \>= 5 years from enrollment
• Blood pressure that is not controlled despite \> 2 oral agents (systolic blood pressure \[SBP\] \> 160 and diastolic blood pressure \[DBP\] \> 90 documented during the screening period with no subsequent blood pressure readings \< 160/100)
• Serum potassium (K)+ \< 3.5 mmoL/L on more than one reading within the screening period
• Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
• Active psychiatric illness/social situations that would limit compliance with protocol requirements
• New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
• Concurrent therapy with strong inhibitors or inducers of Cytochrome P450 (CYP)3A4 due to concerning possible drug-drug interactions with abiraterone

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60430, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

• Heiss BL, Geynisman DM, Martinez E, Wong ASC, Yong WP, Szmulewitz RZ, Stadler WM. Comparison of out-of-pocket costs and adherence between the two arms of the prospective, randomized abiraterone food effect trial. Support Care Cancer. 2022 Mar;30(3):2803-2810. doi: 10.1007/s00520-021-06670-3. Epub 2021 Nov 29.

  PMID: 34845502 DERIVED

• Szmulewitz RZ, Peer CJ, Ibraheem A, Martinez E, Kozloff MF, Carthon B, Harvey RD, Fishkin P, Yong WP, Chiong E, Nabhan C, Karrison T, Figg WD, Stadler WM, Ratain MJ. Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer. J Clin Oncol. 2018 May 10;36(14):1389-1395. doi: 10.1200/JCO.2017.76.4381. Epub 2018 Mar 28.

  PMID: 29590007 DERIVED

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

Results Point of Contact

• Title: Theodore Karrison
• Organization: University of Chicago

tkarrison@health.bsd.uchicago.edu

773-702-9326

Study Officials

• Russell Szmulewitz

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: March 5, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-07

Locations

US (5); SG (1)