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Ovarian CancerPhase 2NCT00569257

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

A Phase 2 study testing AEZS-108 in people with Ovarian Cancer and Endometrial Cancer, run by AEterna Zentaris at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Endometrial Cancer
What is being tested?
AEZS-108
Type of treatment
Injection or infusion
How many people
85 participants
Where
17 sitesin 2 countries
Study dates
Dec 2007to Jul 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

Germany14 sites

  • Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum

    Berlin, D-13353

  • Frauenklinik, Klinikum Bremen-Mitte GmbH

    Bremen, D-28177

  • Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg

    Erlangen, D-91094

  • Universitätsfrauenklinik, Universitätsklinikum

    Essen, D-45122

  • Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt

    Frankfurt am Main, D-60591

  • Frauenklinik, Georg-August-Universität Göttingen

    Göttingen, D-37075

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

    Greifswald, D-17487

  • Frauenklinik, Medizinische Hochschule Hannover

    Hanover, D-30625

  • Frauenklinik, St. Vincentius Kliniken AG

    Karlsruhe, D-76135

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

    Kiel, D-24105

  • Frauenklinik, Klinikum Lüneburg

    Lüneburg, D-21339

  • Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik

    Rostock, D-18059

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

    Wiesbaden, D-65199

Other trials in Germany

Bulgaria3 sites

  • University Hospital "Dr. Georgy Stranski"

    Pleven, BG-5800

  • Regional Oncology Hospital Plovdiv

    Plovdiv, BG-4002

  • Regional Oncodispensary "M.Markov"

    Varna, BG-9010

Other trials in Bulgaria

About this study

Official title: 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)

Read the 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.

Being tested
AEZS-108
Keywords
LHRH receptor, receptor positive tumors, platinum resistant ovarian cancer
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AEZS-108Drug

    Also called AN-152

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to six 3-weekly treatment cycles

Secondary outcomes (2)

  1. Time-to-progression (TTP); Overall survival

    Measured: up to observation of event

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

    Measured: 4 weeks beyond last drug admnistration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569257
Sponsor's protocol ID
AEZS-108-040
Other IDs
AGO-GYN 5, EudraCT No. 2007-002663-26
Status last verified
Dec 2011
First submitted
6 Dec 2007
Last updated
13 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AEZS-108 in people with Ovarian Cancer and Endometrial Cancer, run by AEterna Zentaris at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.

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