Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034489
Status:
COMPLETED
Last Update Posted:
2006-07-19
First Post:
2002-04-29
Brief Title:
A Phase II Study of a Combination of MTA LY231514 and Gemcitabine in Patients With Metastatic Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase II Study of a Combination of MTA LY231514 and Gemcitabine in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs
Detailed Description:
Gemcitabine is given by vein over 30 minutes on days 1 8 of each 21-day cycle LY231514 is also given by vein over 10 minutes on day 8 following the Gemcitabine injection Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514 and continuing throughout the patients participation Vitamin B12 is administered approximately every 9 weeks after the first injection Appropriate antiemetic medication should be given to all patients Dexamethasone 4mg PO twice daily is given for 3 days per cycle beginning 1 day prior to LY231514 dosing This is given to prevent or lessen the possibility of a rash
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 |
|---|---|---|---|
| H3E-MC-JMCF | None | None | None |