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NCT01735396 · ClinicalTrials.gov registry record · Phase 2
Abiraterone Acetate Trial in African American Prostate Cancer Patients
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01735396: Clinical Trial Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01735396 is a Phase 2 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01735396, a Phase 2 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.
Primary Outcome
The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.
Interventions
- DRUG Abiraterone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
Why NCT01735396 stopped before completion
NCT01735396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Abiraterone Acetate is the first listed.
NCT01735396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01735396 about?
NCT01735396 is a clinical study titled "Abiraterone Acetate Trial in African American Prostate Cancer Patients". This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patient...
What is the current status of trial NCT01735396?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2012-12. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01735396?
The interventions under investigation include: Abiraterone Acetate (DRUG).
Who is sponsoring clinical trial NCT01735396?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01735396's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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