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NCT01240629 · ClinicalTrials.gov registry record · Phase 1
Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01240629: Completed Phase 1 study, sponsored by University of Southern California.
NCT01240629 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240629, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a research study for advanced prostate cancer. An experimental drug called AN-152 (also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152. The participants tumor will be tested for expression of this receptor (using an old biopsy). If the participants cancer does not have this receptor, participants will not be eligible to participant in this study. AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended. Participants will continue treatment until death, disease progression, unacceptable toxicity, participants refusal, treatment delay \>3 weeks, or the completion of 6 cycles. Continuation beyond 6 cycles is left at the discretion of the study doctor. The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37 for the Phase II portion).
Interventions
- OTHER laboratory biomarker analysis
- OTHER questionnaire administration
- DRUG doxorubicin-GnRH agonist conjugate AEZS-108
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-11-02 |
| Est. Completion | 2017-02-02 |
| Phase | Phase 1 |
What the finished NCT01240629 record still lists
NCT01240629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01240629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240629 about?
NCT01240629 is a clinical study titled "Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer". This is a research study for advanced prostate cancer. An experimental drug called AN-152 (also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152. The participants tumor will be tested for expression of ...
What is the current status of trial NCT01240629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2010-11-02. Estimated completion is 2017-02-02.
What interventions are being tested in trial NCT01240629?
The interventions under investigation include: laboratory biomarker analysis (OTHER), questionnaire administration (OTHER), doxorubicin-GnRH agonist conjugate AEZS-108 (DRUG).
Who is sponsoring clinical trial NCT01240629?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01240629's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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