Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477464
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2007-05-22
Brief Title:
Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Clinical Evaluation of Lapatinib Administered With Capecitabine in Japanese Patients With ErbB2 Overexpressing Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-09
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:
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients The study will proceed in two phases the first phasePart1 will lead to an evaluation of the mainly tolerability as well as PK parameters If there are no major safety concerns in Part 1 the study will move into the second phase Part 2 to further evaluate the safety and clinical activity
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