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NCT01913015 · ClinicalTrials.gov registry record · Phase 1
Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01913015: Clinical Trial Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT01913015 is a Phase 1 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01913015, a Phase 1 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
The cross-over difference (log\[AUC0-24(low fat)\] - log\[AUC0-24(high fat)\]) of each patient will be computed and graphically illustrated. The cross-over difference will be estimated and reported with 95% confidence interval. Hills-Armitage approach will be used to adjust for the period effect for the estimation. In addition, a bioequivalence range will be computed for the log(AUC0-24\[1000 mg with fasting food\]), allowing for 20% differences in each side.
Interventions
- DRUG abiraterone acetate
- OTHER questionnaire administration
- OTHER pharmacological study
- DIETARY_SUPPLEMENT dietary intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-07 |
| Phase | Phase 1 |
Why NCT01913015 stopped before completion
NCT01913015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which abiraterone acetate is the first listed.
NCT01913015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01913015 about?
NCT01913015 is a clinical study titled "Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer". 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...
What is the current status of trial NCT01913015?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2013-07.
What interventions are being tested in trial NCT01913015?
The interventions under investigation include: abiraterone acetate (DRUG), questionnaire administration (OTHER), pharmacological study (OTHER), dietary intervention (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01913015?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01913015's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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