Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 4:41 PM
Study NCT ID:
NCT00856050
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).
Detailed Description:
* Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:
* Visit 1 (Day 1): physical examination, vital signs and blood work
* Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
* Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
* Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse
* Visit 1 (Day 1): physical examination, vital signs and blood work
* Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
* Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
* Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: