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NCT01767155 · ClinicalTrials.gov registry record · Phase 3
Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
A Phase 3 study of Endometrial Cancer, sponsored by AEterna Zentaris.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
- 20
- Study locations
NCT01767155: Completed Phase 3 study of Endometrial Cancer, sponsored by AEterna Zentaris.
NCT01767155 is a Phase 3 study of Endometrial Cancer that has completed, run by AEterna Zentaris. The registered enrollment target is 511 participants, roughly in line with the 521-participant average among 181 other Endometrial Cancer trials with a reported enrollment target. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01767155, a Phase 3 study of Endometrial Cancer, has completed, sponsored by AEterna Zentaris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
- 20
- Study locations
Study Summary
Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.
Primary Outcome
Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact. The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died. A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIF
Conditions Studied
Interventions
- DRUG doxorubicin
- DRUG AEZS-108 / zoptarelin doxorubicin
Study Locations (20)
California
- USC Norris Hospital and LAC+USC Medical Center - Los Angeles
- University of California, Irvine - Medical Center - Orange
Connecticut
- Hartford Hospital - Hartford
- The Hospital of Central Connecticut - New Britain
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
North Carolina
- Hope Women's Cancer Centers / Mission Hospital, Inc. - Asheville
- Levine Cancer Institute - Charlotte
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Colorado
- University of Colorado - Aurora
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Northside Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2013-04 |
| Est. Completion | 2017-01-30 |
| Phase | Phase 3 |
What the finished NCT01767155 record still lists
NCT01767155 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 521-participant average among 181 other Endometrial Cancer trials with a reported enrollment target.
The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which doxorubicin is the first listed.
NCT01767155 names 20 study sites across 16 states, led by California, Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01767155 about?
NCT01767155 is a clinical study titled "Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer". Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.
What is the current status of trial NCT01767155?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2013-04. Estimated completion is 2017-01-30.
What conditions does trial NCT01767155 study?
This clinical trial studies the following conditions: Endometrial Cancer.
What interventions are being tested in trial NCT01767155?
The interventions under investigation include: doxorubicin (DRUG), AEZS-108 / zoptarelin doxorubicin (DRUG).
Who is sponsoring clinical trial NCT01767155?
This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01767155 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
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 NCT01767155's enrollment target sits among peer trials
511 30th of 181 higher than 152 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial 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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