Trials / Completed
CompletedNCT01767155
Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 511 (actual)
- Sponsor
- AEterna Zentaris · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.
Detailed description
The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AEZS-108 / zoptarelin doxorubicin | 267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles |
| DRUG | doxorubicin | 60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2017-01-30
- Completion
- 2017-01-30
- First posted
- 2013-01-14
- Last updated
- 2018-07-31
- Results posted
- 2018-07-31
Locations
123 sites across 22 countries: United States, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Romania, Russia, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01767155. Inclusion in this directory is not an endorsement.