NCT01965080

Brief 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%

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

4.9 years

First QC Date

September 26, 2013

Last Update Submit

October 15, 2013

Conditions

Endometrial Cancer

Keywords

Endometrial cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Objective response rate within 6 months of treatment

    6 months

Secondary Outcomes (1)

  • Progression free survival

    2 years

Other Outcomes (1)

  • Toxicity

    Up to 2 years

Study Arms (1)

Exemestane

EXPERIMENTAL

Exemestane 25 mg daily

Drug: Exemestane

Interventions

ExemestaneDRUG

One tablet Exemestane 25 mg daily

Also known as: Aromasin
Exemestane

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian Radium Hospital

Oslo, 0310, Norway

Location

Related Publications (1)

  • 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.

    PMID: 24498853DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Gunnar Kristensen, MD, PhD

    NSGO

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 18, 2013

Study Start

March 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

NO(1)