drugset / Trial / NCT01913015

Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT01913015 ↗

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2013-07
Primary completion
2014-06
Completion
—

Outcome

Outcome not reported

Stopped (Enrollment): “After enrollment of the first 3 subjects, an interim assessment was conducted. Comparing DBS sampling to plasma PK levels yielded unconvincing results.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 250 mg Oral