Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146172
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2005-09-02
Brief Title:
Study Evaluating HKI-272 in Tumors
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
Official Title:
An Ascending Single and Multiple Dose Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2NEU or HER-1EGFR-Positive Tumors
Status:
COMPLETED
Status Verified Date:
2018-08
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 evaluate the safety and tolerability as well as find the maximum tolerated dose MTD for HKI-272 In addition this study will examine the effects of the study drug on your tumor and how your body uses and eliminates HKI-272
Detailed Description:
None
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