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

NCT ID: NCT00569257

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-07-31

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Ovarian Cancer Endometrial Cancer

Keywords

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LHRH receptor receptor positive tumors platinum resistant ovarian cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AEZS-108

intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles

Intervention Type DRUG

Other Intervention Names

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AN-152

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AGO Study Group

OTHER

Sponsor Role collaborator

AEterna Zentaris

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Günter Emons, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen

Locations

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University Hospital "Dr. Georgy Stranski"

Pleven, , Bulgaria

Site Status

Regional Oncology Hospital Plovdiv

Plovdiv, , Bulgaria

Site Status

Regional Oncodispensary "M.Markov"

Varna, , Bulgaria

Site Status

Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Frauenklinik, Klinikum Bremen-Mitte GmbH

Bremen, , Germany

Site Status

Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg

Erlangen, , Germany

Site Status

Universitätsfrauenklinik, Universitätsklinikum

Essen, , Germany

Site Status

Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt

Frankfurt am Main, , Germany

Site Status

Frauenklinik, Georg-August-Universität Göttingen

Göttingen, , Germany

Site Status

Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe

Greifswald, , Germany

Site Status

Frauenklinik, Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Frauenklinik, St. Vincentius Kliniken AG

Karlsruhe, , Germany

Site Status

Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status

Frauenklinik, Klinikum Lüneburg

Lüneburg, , Germany

Site Status

Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik

Rostock, , Germany

Site Status

Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH

Wiesbaden, , Germany

Site Status

Countries

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Bulgaria Germany

Related Links

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http://www.ago-ovar.de

AGO Studiengruppe Ovarialkarzinom

Other Identifiers

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AGO-GYN 5

Identifier Type: -

Identifier Source: secondary_id

EudraCT No. 2007-002663-26

Identifier Type: -

Identifier Source: secondary_id

AEZS-108-040

Identifier Type: -

Identifier Source: org_study_id