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Exemestane in Advanced and Recurrent Endometrial Carcinoma

Information source: Nordic Society for Gynaecologic Oncology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrial Cancer

Intervention: Exemestane (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Nordic Society for Gynaecologic Oncology

Official(s) and/or principal investigator(s):
Gunnar Kristensen, MD, PhD, Study Chair, Affiliation: NSGO

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%

Clinical Details

Official title: Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response rate

Secondary outcome: Progression free survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

The Norwegian Radium Hospital, Oslo 0310, Norway
Additional Information

Starting date: March 2004
Last updated: October 15, 2013

Page last updated: August 20, 2015

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