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NCT01615120 · ClinicalTrials.gov registry record · Phase 2
Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by GTx.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 20
- Study locations
NCT01615120: Completed Phase 2 study of Prostate Cancer, sponsored by GTx.
NCT01615120 is a Phase 2 study of Prostate Cancer that has completed, run by GTx. The registered enrollment target is 77 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615120, a Phase 2 study of Prostate Cancer, has completed, sponsored by GTx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 20
- Study locations
Study Summary
Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy. This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.
Primary Outcome
The percentage of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120)
Conditions Studied
Interventions
- DRUG GTx-758 125 mg
- DRUG GTx-758 250 mg
Study Locations (20)
California
- Urology Associates Medical Group - Burbank
- VA of Greater Los Angeles - Los Angeles
- Tower Urology - Los Angeles
- San Bernardino Urological Assoc. - San Bernardino
- Genesis Healthcare Partners - San Diego
- Urology Specialists of So. California - Torrance
Florida
- So. Florida Medical Research - Aventura
- AMPM Research - Miami
- Coastal Medical Center - Sarasota
- GTx Investigative Site - St. Petersburg
- Pinellas Urology - St. Petersburg
New York
- Urological Institute of NE New York - Albany
- AMP of NY - Oneida
- AMP of NY - Syracuse
Indiana
- Urology of Indiana - Greenwood
- First Urology PSC - Jeffersonville
Colorado
- Univ. of Colorado Cancer Center - Aurora
Connecticut
- Connecticut Clinical Research Center - Middlebury
Maryland
- Chesapeake Urology Research Assoc. - Towson
Montana
- Five Valleys Urology - Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-08-14 |
| Est. Completion | 2016-11-09 |
| Phase | Phase 2 |
What the finished NCT01615120 record still lists
NCT01615120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which GTx-758 125 mg is the first listed.
NCT01615120 names 20 study sites across 8 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT01615120 about?
NCT01615120 is a clinical study titled "Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer". Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing ...
What is the current status of trial NCT01615120?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2012-08-14. Estimated completion is 2016-11-09.
What conditions does trial NCT01615120 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01615120?
The interventions under investigation include: GTx-758 125 mg (DRUG), GTx-758 250 mg (DRUG).
Who is sponsoring clinical trial NCT01615120?
This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01615120 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01615120's enrollment target sits among peer trials
77 385th of 735 higher than 349 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.
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