Exemestane in Advanced and Recurrent Endometrial Carcinoma | NCT01965080

Studies
Exemestane in Advanced and Recurrent Endometrial Carcinoma

NCT01965080

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Status

Completed

Last Update Posted

Oct 18, 2013Estimated

Enrollment

52Actual

Phase

Phase 2

Conditions

Endometrial Cancer

Interventions

Exemestane

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 26, 2013

First Submission Date that Met QC Criteria

Oct 15, 2013

First Posted Date

Oct 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2013

Last Update Posted Date

Oct 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exemestane	Experimental	Exemestane 25 mg daily	Drug: Exemestane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exemestane	Drug	One tablet Exemestane 25 mg daily	Exemestane	Aromasin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	Objective response rate within 6 months of treatment	6 months

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival	Special attention to progression status at 6 months	2 years

Other Outcomes

Measure	Description	Time Frame
Toxicity	Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects	Up to 2 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Kristensen, MD, PhD	NSGO	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Norwegian Radium Hospital		Oslo		0310	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24498853	Derived	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.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site