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Steroidogenesis Inhibitor
Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer
Phase 1
Waitlist Available
Led By Tomasz Beer
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours (day 1)
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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. Eating a low or high fat diet may increase the uptake of abiraterone acetate.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours (day 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours (day 1)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area under the curve (AUC)0-24 measurement
Secondary study objectives
Accuracy of patient-collected DBS sampling technique
Patient adherence to pre-defined sampling schedule
Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (abiraterone acetate, high then low fat breakfast)Experimental Treatment5 Interventions
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.
Group II: Arm I (abiraterone acetate, low then high fat breakfast)Experimental Treatment5 Interventions
Patients 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
dietary intervention
2000
Completed Phase 2
~600
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,089,569 Total Patients Enrolled
17 Trials studying Prostate Cancer
579 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,577 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Tomasz BeerPrincipal InvestigatorOHSU Knight Cancer Institute
2 Previous Clinical Trials
51 Total Patients Enrolled