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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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01289067
The ClinicalTrials.gov registry entry for NCT01289067 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The listed sponsor is William K. Oh, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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