Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003669
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
1999-11-01
Brief Title:
Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent Advanced or Metastatic Endometrial Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2008-04
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:
RATIONALE Estrogen can stimulate the growth of endometrial cancer cells Hormone therapy using arzoxifene hydrochloride may fight the endometrial cancer by blocking the use of estrogen by the tumor cells
PURPOSE This phase II trial is studying how well arzoxifene hydrochloride works in treating women with recurrent advanced or metastatic endometrial cancer
PURPOSE This phase II trial is studying how well arzoxifene hydrochloride works in treating women with recurrent advanced or metastatic endometrial cancer
Detailed Description:
OBJECTIVES I Determine the objective tumor response rate complete response and partial response to arzoxifene hydrochloride in patients with recurrent or advanced endometrial cancer II Determine the time to progressive disease time to treatment failure response duration and survival in patients with recurrent or advanced endometrial cancer receiving arzoxifene hydrochloride III Assess the safety of this treatment in these patients IV Measure changes in serum estradiol follicle stimulating hormone luteinizing hormone and sex hormone binding globulin during this treatment in these patients
OUTLINE Patients receive oral arzoxifene hydrochloride daily at a fixed dose Treatment continues in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL Not specified
National Cancer Institute NCI registered this trial with Eli Lilly as sponsor NCI did not update the record when the trial completed In June 2012 NCI transferred the trial to Lillys clinicaltrialsgov account and Lilly updated the record with the trial completion date This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 FDAAA
OUTLINE Patients receive oral arzoxifene hydrochloride daily at a fixed dose Treatment continues in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL Not specified
National Cancer Institute NCI registered this trial with Eli Lilly as sponsor NCI did not update the record when the trial completed In June 2012 NCI transferred the trial to Lillys clinicaltrialsgov account and Lilly updated the record with the trial completion date This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 FDAAA
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066766 | None | None | None |
| LILLY-H4Z-MC-JWWI | None | None | None |
| MSKCC-99001 | None | None | None |