Endometrial CancerPhase 2NCT01965080
Exemestane in Advanced and Recurrent Endometrial Carcinoma
A Phase 2 study testing Exemestane in people with Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2004to Feb 2009
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
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.
- Conditions
- Endometrial Cancer
- Being tested
- Exemestane
- Keywords
- Endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Aromasin
One tablet Exemestane 25 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Exemestane | Experimental | Exemestane 25 mg daily Receives: Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Objective response rate within 6 months of treatment
Measured: 6 months
Secondary outcomes (1)
Progression free survival
Special attention to progression status at 6 months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startMar 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Kristensen, MD, PhD, Study chair, NSGO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965080
- Sponsor's protocol ID
- NSGO-EC-0302
- Status last verified
- Oct 2013
- First submitted
- 26 Sep 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT01965080
- Acronym / sponsor ID
- NSGO-EC-0302
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane | Experimental | Drug: ExemestaneExemestane 25 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Congestive heart disease grade III.IV
- History of thromboembolic signs
- Other primary hormonal therapy
- Patients With symptomatic brain metastasis
- Severe hepatic or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExemestaneAlso: AromasinOne tablet Exemestane 25 mg daily | Drug | Exemestane |
Primary outcome
Response rate
Time frame: 6 months
Objective response rate within 6 months of treatment
1 secondary outcome
Progression free survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
- Derived from this study: PubMed 24498853Lindemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Kristensen, MD, PhD study chair
NSGO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exemestane in people with Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Norway.
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 6 inclusion and 6 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 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Response rate (time frame: 6 months). 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 NCT01965080, which also lists 1 linked publication.
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 18 Oct 2013.