Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322400
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2006-05-04
Brief Title:
Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-label Dose-finding Study to Evaluate the Safety of AMG 706 in Combination With Paclitaxel or Docetaxel as Treatment for Locally Recurrent or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 open-label dose-finding multi-center study is designed to determine the safety and the maximum tolerated dose of AMG 706 given once daily in combination with either weekly paclitaxel Arm A or once-every-3 week docetaxel Arm B in subjects with locally recurrent or metastatic breast cancer Secondarily this study will evaluate the pharmacokinetic PK profile of AMG 706 in both treatment arms the PK profile of paclitaxel in Arm A and the PK profile of docetaxel in Arm B Additionally this study will assess objective tumor response and duration of response Exploratory endpoints include the investigation of potential biomarker development and to assess the effects of genetic variation in drug metabolism genes cancer genes and drug target genes on subject response to AMG 706 in combination with paclitaxel or docetaxel
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