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NCT01685268 · ClinicalTrials.gov registry record · Phase 1
A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate
A Phase 1 study of Prostate Cancer, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 20
- Study locations
NCT01685268: Completed Phase 1 study of Prostate Cancer, sponsored by Astex Pharmaceuticals.
NCT01685268 is a Phase 1 study of Prostate Cancer that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 49 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01685268, a Phase 1 study of Prostate Cancer, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 20
- Study locations
Study Summary
A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same doses of abiraterone and steroids they were receiving prior to study entry and will be randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with abiraterone. Once the best regimen is established in Part A, based on safety and antitumor activity, patients will be randomized to the selected treatment regimen and dose of AT13387 in combination with abiraterone or AT13387 alone in Part B (Phase 2).
Primary Outcome
* Number of patients with adverse events * Change in prostate specific antigen measurement and circulating tumor cell count every 4 weeks * Change in tumor measurements by RECIST 1.1 every 12 weeks
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG abiraterone acetate
- DRUG AT13387
Study Locations (20)
New York
- Roswell Park Cancer Institute - Buffalo
- Clinical Research Alliance, Inc. - Lake Success
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- SUNY Upstate Medical University - Syracuse
Florida
- Holy Cross Hospital - Fort Lauderdale
- Florida Cancer Specialists-Fort Myers - Fort Myers
- Lakeland Regional Cancer Center - Lakeland
California
- University of California, Los Angeles Institute of Urologic Oncology - Los Angeles
- Stanford Cancer Center - Stanford
Maryland
- University of Maryland, Greenebaum Cancer Center - Baltimore
- Center for Cancer & Blood Disorders - Bethesda
Illinois
- Southern Illinois University School of Medicine - Springfield
Missouri
- Washington University School of Medicine - St Louis
Nebraska
- University of Nebraska Medical Center - Omaha
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01685268 record still lists
NCT01685268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Prednisone is the first listed.
NCT01685268 names 20 study sites across 12 states, led by New York, Florida, California.
Frequently Asked Questions
What is clinical trial NCT01685268 about?
NCT01685268 is a clinical study titled "A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate". A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same doses of abiraterone and steroids th...
What is the current status of trial NCT01685268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-09. Estimated completion is 2014-12.
What conditions does trial NCT01685268 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01685268?
The interventions under investigation include: Prednisone (DRUG), abiraterone acetate (DRUG), AT13387 (DRUG).
Who is sponsoring clinical trial NCT01685268?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01685268 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Missouri. 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 NCT01685268's enrollment target sits among peer trials
49 490th of 735 higher than 241 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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