Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034281
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2002-04-24
Brief Title:
Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase I Open-Label Dose Escalating Multiple Dose Study to Determine the Safety Tolerability Maximum Tolerated Dose and Pharmacokinetics of Oral TAK-165 Administered Once Daily to Subjects With Tumors Known to Express HER2
Status:
COMPLETED
Status Verified Date:
2012-01
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 investigate a safe dose of TAK-165 once daily QD in patients with HER2-tumor expression
Detailed Description:
The human epidermal growth factor receptor 2 HER2 is a member of the Type 1 family of growth factor tyrosine kinases HER2 forms hetero- and homo-dimers with other members of this family of tyrosine kinases As a result of dimerization at the cell surface intracellular signal transduction is initiated resulting in cell proliferation
HER2 expression has been observed in a variety of human tumors including breast cancer non-small cell lung cancer prostate cancer pancreatic cancer renal cell cancer and ovarian cancer HER2 overexpression is associated with clinically more aggressive breast cancer and is an independent predictor of poor prognosis in patients with breast cancer
TAK-165 is an active and selective inhibitor of tyrosine kinase activity of HER2 being developed for patients with lower levels of HER2 expression This study will seek to determine the safety tolerability maximum tolerated dose and pharmacokinetics of TAK-165 administered to subjects with tumors known to express HER2
The total duration of the study will be at minimum 8 weeks or 56 Days Subjects without progressive disease after 8 weeks may continue to receive study drug provided that they do not meet criteria for withdrawal
HER2 expression has been observed in a variety of human tumors including breast cancer non-small cell lung cancer prostate cancer pancreatic cancer renal cell cancer and ovarian cancer HER2 overexpression is associated with clinically more aggressive breast cancer and is an independent predictor of poor prognosis in patients with breast cancer
TAK-165 is an active and selective inhibitor of tyrosine kinase activity of HER2 being developed for patients with lower levels of HER2 expression This study will seek to determine the safety tolerability maximum tolerated dose and pharmacokinetics of TAK-165 administered to subjects with tumors known to express HER2
The total duration of the study will be at minimum 8 weeks or 56 Days Subjects without progressive disease after 8 weeks may continue to receive study drug provided that they do not meet criteria for withdrawal
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1127-6123 | REGISTRY | WHO | None |