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Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer

NCT01767155 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2018-07-31

Study results available
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Summary

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.

Conditions

Interventions

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

Sponsors & Collaborators

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • David S Miller, MD · University of Texas Southwestern Medical Center, Dallas, USA

  • Hani Gabra, MD · Imperial College London Hammersmith Campus, London, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-01-30
Completion
2017-01-30
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01767155 on ClinicalTrials.gov