Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398567
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2006-11-09
Brief Title:
A Phase 12 Study Of HKI-272 Neratinib in Combination With Trastuzumab Herceptin In Subjects With Advanced Breast Cancer
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
Official Title:
A Phase III Study of HKI-272 in Combination With Trastuzumab Herceptin in Subjects With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The purpose of this study is to determine the safety and efficacy of HKI-272 neratinib in combination with trastuzumab in patients with advanced breast cancer
Detailed Description:
Open label phase 12 study of ascending multiple oral doses of HKI-272 in combination with IV trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive HER2 breast cancer Three to six subjects will be enrolled in each dose group Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21 When the maximum tolerated dose MTD of HKI-272 plus trastuzumab is determined an additional 30 subjects will be enrolled at that dose level and followed for progression free survival for approximately 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None