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NCT01289067 · ClinicalTrials.gov registry record · Phase 2
Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca
A Phase 2 study of Prostate Cancer, sponsored by William K. Oh.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01289067: Completed Phase 2 study of Prostate Cancer, sponsored by William K. Oh.
NCT01289067 is a Phase 2 study of Prostate Cancer that has completed, run by William K. Oh. The registered enrollment target is 13 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01289067, a Phase 2 study of Prostate Cancer, has completed, sponsored by William K. Oh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to test genes for BRCAness(BRCA\[BReast CAncer\] gene) Studying these genes could help predict which patients would benefit from treatment with satraplatin, a medication being used for subjects who have failed prior chemotherapy. All subjects will have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene signature may be able to predict response to satraplatin and a tool will be developed to be able to screen patients likely to benefit from satraplatin. Subjects will all receive Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered responders if they have measurable disease meeting criteria for partial or complete response. PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.
Primary Outcome
Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.
Conditions Studied
Interventions
- DRUG Satraplatin
Study Locations (1)
New York
- Mount Sinai Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01289067 record still lists
NCT01289067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Satraplatin is the first listed.
NCT01289067 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01289067 about?
NCT01289067 is a clinical study titled "Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca". The purpose of the study is to test genes for BRCAness(BRCA\[BReast CAncer\] gene) Studying these genes could help predict which patients would benefit from treatment with satraplatin, a medication being used for subjects who have failed prior chemotherapy. All subjects will have a biopsy of metasta...
What is the current status of trial NCT01289067?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2010-12. Estimated completion is 2013-05.
What conditions does trial NCT01289067 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01289067?
The interventions under investigation include: Satraplatin (DRUG).
Who is sponsoring clinical trial NCT01289067?
This trial is sponsored by William K. Oh, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01289067 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01289067's enrollment target sits among peer trials
13 698th of 735 higher than 34 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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