Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 43 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240629
The ClinicalTrials.gov registry entry for NCT01240629 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01240629 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.