Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors

December 12, 2011 updated by: AEterna Zentaris

Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors

The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been shown to express receptors for the luteinizing hormone releasing hormone (LHRH)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ovary and the endometrium are hormone dependent organs. Receptors for different sex hormones are found commonly in epithelial ovarian and endometrial cancers. LHRH and its receptors are expressed in about 80% of human ovarian and endometrial cancers. As binding sites are present on tumors in higher concentrations than on most normal tissues, these receptors represent a specific target for AEZS-108 in which doxorubicin is coupled to an LHRH analog.

Patients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, BG-5800
        • University Hospital "Dr. Georgy Stranski"
      • Plovdiv, Bulgaria, BG-4002
        • Regional Oncology Hospital Plovdiv
      • Varna, Bulgaria, BG-9010
        • Regional Oncodispensary "M.Markov"
  • Germany
      • Berlin, Germany, D-13353
        • Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum
      • Bremen, Germany, D-28177
        • Frauenklinik, Klinikum Bremen-Mitte GmbH
      • Dresden, Germany, D-01307
        • Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus
      • Erlangen, Germany, D-91094
        • Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg
      • Essen, Germany, D-45122
        • Universitätsfrauenklinik, Universitätsklinikum
      • Frankfurt / Main, Germany, D-60591
        • Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt
      • Greifswald, Germany, D-17487
        • Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe
      • Göttingen, Germany, D-37075
        • Frauenklinik, Georg-August-Universität Göttingen
      • Hannover, Germany, D-30625
        • Frauenklinik, Medizinische Hochschule Hannover
      • Karlsruhe, Germany, D-76135
        • Frauenklinik, St. Vincentius Kliniken AG
      • Kiel, Germany, D-24105
        • Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Lüneburg, Germany, D-21339
        • Frauenklinik, Klinikum Lüneburg
      • Rostock, Germany, D-18059
        • Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik
      • Wiesbaden, Germany, D-65199
        • Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor
  • Histologically confirmed epithelial ovarian cancer (Stratum A)
  • Advanced (FIGO III or IV) or recurrent disease
  • Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen
  • Previous treatment with a taxane-containing regimen
  • At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria)
  • Histologically confirmed endometrial cancer (Stratum B)
  • Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative treatment with local surgery and/or radiation therapy
  • No previous anthracycline-based chemotherapy
  • At least one measurable target lesion according to RECIST criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
Time Frame: up to six 3-weekly treatment cycles
up to six 3-weekly treatment cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-to-progression (TTP); Overall survival
Time Frame: up to observation of event
up to observation of event
Safety of AEZS-108 (possibly drug-related adverse events)
Time Frame: 4 weeks beyond last drug admnistration
4 weeks beyond last drug admnistration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AEterna Zentaris

Collaborators

AGO Study Group

Investigators

  • Principal Investigator: Günter Emons, Prof.Dr.med., Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEZS-108-040
  • AGO-GYN 5
  • EudraCT No. 2007-002663-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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