Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01816035
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2013-03-19
Brief Title:
Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Thrombokinetic Studies of Ado-Trastuzumab Emtansine
Status:
COMPLETED
Status Verified Date:
2017-05
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 phase I trial studies the side effects and best way of giving trastuzumab emtansine in treating patients with human epidermal growth factor receptor 2 HER2-positive breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed by surgery Biological therapies such as trastuzumab emtansine may stimulate the immune system in different ways and stop cancer cells from growing
Detailed Description:
PRIMARY OBJECTIVES
I To assess change in thrombokinetics platelet circulation life span
SECONDARY OBJECTIVES
I Benefit rate as defined by stable disease partial response or complete response by Response Evaluation Criteria in Solid Tumors RECIST v 11 at the end of study activities
II To evaluate the safety of trastuzumab emtansine ado-trastuzumab emtansine non-platelet toxicity
III To evaluate the pharmacokinetics of ado-trastuzumab emtansine
OUTLINE
Patients receive trastuzumab emtansine intravenously IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients achieving response may continue treatment
After completion of study treatment patients are followed up periodically
I To assess change in thrombokinetics platelet circulation life span
SECONDARY OBJECTIVES
I Benefit rate as defined by stable disease partial response or complete response by Response Evaluation Criteria in Solid Tumors RECIST v 11 at the end of study activities
II To evaluate the safety of trastuzumab emtansine ado-trastuzumab emtansine non-platelet toxicity
III To evaluate the pharmacokinetics of ado-trastuzumab emtansine
OUTLINE
Patients receive trastuzumab emtansine intravenously IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients achieving response may continue treatment
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| NCI-2013-00552 | REGISTRY | None | None |
| CC-7900 | None | None | None |
| 7900 | OTHER | None | None |
| P30CA015704 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |