NCT00569257

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Dec 2007

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

3.6 years

First QC Date

December 6, 2007

Last Update Submit

December 12, 2011

Conditions

Ovarian CancerEndometrial Cancer

Keywords

LHRH receptorreceptor positive tumorsplatinum resistant ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria

    up to six 3-weekly treatment cycles

Secondary Outcomes (2)

  • Time-to-progression (TTP); Overall survival

    up to observation of event

  • Safety of AEZS-108 (possibly drug-related adverse events)

    4 weeks beyond last drug admnistration

Interventions

AEZS-108DRUG

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

Also known as: AN-152

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University Hospital "Dr. Georgy Stranski"

Pleven, BG-5800, Bulgaria

Location

Regional Oncology Hospital Plovdiv

Plovdiv, BG-4002, Bulgaria

Location

Regional Oncodispensary "M.Markov"

Varna, BG-9010, Bulgaria

Location

Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum

Berlin, D-13353, Germany

Location

Frauenklinik, Klinikum Bremen-Mitte GmbH

Bremen, D-28177, Germany

Location

Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg

Erlangen, D-91094, Germany

Location

Universitätsfrauenklinik, Universitätsklinikum

Essen, D-45122, Germany

Location

Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt

Frankfurt am Main, D-60591, Germany

Location

Frauenklinik, Georg-August-Universität Göttingen

Göttingen, D-37075, Germany

Location

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

Greifswald, D-17487, Germany

Location

Frauenklinik, Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Frauenklinik, St. Vincentius Kliniken AG

Karlsruhe, D-76135, Germany

Location

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

Kiel, D-24105, Germany

Location

Frauenklinik, Klinikum Lüneburg

Lüneburg, D-21339, Germany

Location

Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik

Rostock, D-18059, Germany

Location

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

Wiesbaden, D-65199, Germany

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial Neoplasms

Interventions

LHRH, lysine(6)-doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • Günter Emons, Prof.Dr.med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

BU(3)DE(14)