NCT00333086

Brief Summary

Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 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

January 1, 2000

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

6.4 years

First QC Date

June 1, 2006

Last Update Submit

April 18, 2012

Conditions

Recurrent and Metastatic Endometrial Cancer

Keywords

Endometrial CancerAromatase inhibitorLetrozole

Outcome Measures

Primary Outcomes (1)

  • Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks

Secondary Outcomes (1)

  • Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels

Interventions

LetrozoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
  • No adjuvant therapy
  • Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
  • No chemotherapy for recurrence (adjuvant permitted)
  • Unidimensionally measurable disease
  • Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
  • No prior tamoxifen or aromatase inhibitor therapy
  • No other concurrent anti-cancer treatment
  • No metastases in the central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Heidelberg, Germany

Location

MeSH Terms

Conditions

RecurrenceEndometrial Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

January 1, 2000

Primary Completion

June 1, 2006

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

DE(1)