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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569257
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : December 13, 2011
AGO Study Group
Information provided by (Responsible Party):
AEterna Zentaris

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Ovarian Cancer Endometrial Cancer Drug: AEZS-108 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors
Study Start Date : December 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Intervention Details:
  • Drug: AEZS-108
    intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles
    Other Name: AN-152

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time-to-progression (TTP); Overall survival [ Time Frame: up to observation of event ]
  2. Safety of AEZS-108 (possibly drug-related adverse events) [ Time Frame: 4 weeks beyond last drug admnistration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569257

Show Show 17 study locations
Sponsors and Collaborators
AEterna Zentaris
AGO Study Group
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Principal Investigator: Günter Emons, Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen

Additional Information:
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Responsible Party: AEterna Zentaris Identifier: NCT00569257    
Other Study ID Numbers: AEZS-108-040
EudraCT No. 2007-002663-26
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011
Keywords provided by AEterna Zentaris:
LHRH receptor
receptor positive tumors
platinum resistant ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action