Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338247
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2016-04-06
First Post:
2006-06-16
Brief Title:
EAP Expanded Access Protocol Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2016-04
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 study will provide pre-approval drug access to lapatinib in combination with capecitabine to patients whose breast cancer had progressed on other therapies
Detailed Description:
None
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