Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397046
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2006-11-07
Brief Title:
A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
Official Title:
An Ascending and Multiple Dose Study of the Safety Tolerability and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid 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 assess the tolerability and safety of HKI-272 and to determine the maximum dose that can safety be given The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors
Detailed Description:
This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors Each subject will participate in only 1 dose group and will receive a single dose of test article followed by a 1-week observation period and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days Subjects will be enrolled in groups of 3 to 6 Adverse events and dose-limiting toxicities will be assessed from the first single dose
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