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CompletedNCT01965080Updated Oct 18, 2013

Exemestane in Advanced and Recurrent Endometrial Carcinoma

A Phase 2 interventional study of Exemestane in Endometrial Cancer, sponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit. Completed at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-18.

Sponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma

Hypothesis: Treatment With Exemestane can give a response rate of at least 30%

Read the detailed description

Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.

Patients were grouped according to estrogen receptor status.

02

Conditions studied

  • Endometrial Cancer

Keywords

  • Endometrial cancer
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 52 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment
  • Endometrioid histology
  • Age above 18 years
  • Post menopausal status
  • Performance status 0-2
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Congestive heart disease grade III.IV
  • History of thromboembolic signs
  • Other primary hormonal therapy
  • Patients With symptomatic brain metastasis
  • Severe hepatic or renal impairment
  • Pregnancy, lactation or child bearing potential without adequate contraception
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Exemestane

    Exemestane 25 mg daily

    Drug: Exemestane

Interventions

  • DrugExemestane

    One tablet Exemestane 25 mg daily

    Also known as: Aromasin

06

What researchers measure

Primary outcomes

  1. Response rate

    Objective response rate within 6 months of treatment

    Time frame: 6 months

Secondary outcomes

  1. Progression free survival

    Special attention to progression status at 6 months

    Time frame: 2 years

Other outcomes

  1. Toxicity

    Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects

    Time frame: Up to 2 years

07

Study locations

1 site
  • The Norwegian Radium Hospital
    Oslo, 0310, Norway
08

References and documents

Publications

  • Lindemann K, Malander S, Christensen RD, Mirza MR, Kristensen GB, Aavall-Lundqvist E, Vergote I, Rosenberg P, Boman K, Nordstrom B. Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO). BMC Cancer. 2014 Feb 5;14:68. doi: 10.1186/1471-2407-14-68. PubMed 24498853 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01965080
Lead sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Responsible party
Sponsor
First posted
Oct 18, 2013
Start date
Mar 2004
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Oct 18, 2013

Study contacts

Gunnar Kristensen, MD, PhD
study chair · NSGO

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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