Exemestane in Advanced and Recurrent Endometrial Carcinoma

NCT ID: NCT01965080

Last Updated: 2013-10-18

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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

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Endometrial Cancer

Keywords

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Endometrial cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exemestane

Exemestane 25 mg daily

Group Type EXPERIMENTAL

Exemestane

Intervention Type DRUG

One tablet Exemestane 25 mg daily

Interventions

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Exemestane

One tablet Exemestane 25 mg daily

Intervention Type DRUG

Other Intervention Names

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Aromasin

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Kristensen, MD, PhD

Role: STUDY_CHAIR

NSGO

Locations

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The Norwegian Radium Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 24498853 (View on PubMed)

Other Identifiers

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NSGO-EC-0302

Identifier Type: -

Identifier Source: org_study_id