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NCT00918385 · ClinicalTrials.gov registry record · Phase 2
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00918385: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT00918385 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00918385, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a phase II multi-center study to determine the clinical impact of using a patient-specific genomic expression signature of androgen receptor (AR) activity to determine therapy for patients with castration-resistant metastatic prostate cancer (CRPC). After patient eligibility is determined, the genomic signature will be applied to fresh frozen tissue harvested from a metastatic lesion during image-guided biopsy. After assessing for androgen receptor activity, the investigators will select patients for either continued androgen manipulation with nilutamide (high AR activity) or targeted therapy with dasatinib (low AR activity). Once patients develop a first progression on either arm, patients will receive combination therapy with dasatinib and nilutamide. The primary aim is to estimate the median progression free survival in men with CRPC treated according to tumor AR activity. The investigators hypothesize that by treating men based upon AR activity, median progression free survival (PFS) will improve from a historical median of 3.0 months to 6.0 months.
Primary Outcome
PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.
Interventions
- DRUG Dasatinib
- DRUG Nilutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Why NCT00918385 stopped before completion
NCT00918385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Dasatinib is the first listed.
NCT00918385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00918385 about?
NCT00918385 is a clinical study titled "Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer". This is a phase II multi-center study to determine the clinical impact of using a patient-specific genomic expression signature of androgen receptor (AR) activity to determine therapy for patients with castration-resistant metastatic prostate cancer (CRPC). After patient eligibility is determined, t...
What is the current status of trial NCT00918385?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2009-05. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00918385?
The interventions under investigation include: Dasatinib (DRUG), Nilutamide (DRUG).
Who is sponsoring clinical trial NCT00918385?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00918385's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 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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