Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04620187
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2020-11-02
Brief Title:
Post-op T-DM1 in HER-2 Salivary Gland Carcinomas
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Adjuvant Ado-trastuzumab Emtansine T-DM1 in HER2-positive Salivary Gland Carcinomas
Status:
RECRUITING
Status Verified Date:
2024-04
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 research is being done to see how safe and effective the use of the study drug Ado-trastuzumab T emtansine DM1 T-DM1 and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer It will also examine the effectiveness of study drug Ado-trastuzumab T emtansine DM1 on cancer recurrence
Detailed Description:
This is a phase II open-label non-randomized multi-institutional study investigating postoperative or adjuvant human epidermal growth factor receptor HER2-directed therapy with adjuvant ado-trastuzumab emtansine T-DM1 in HER2-positive salivary gland carcinomas SGC
This research study is
Studying the use of T-DM1 in combination with radiation and chemotherapy and the use of maintenance T-DM1 alone for up to a year after surgery
Evaluating the effectiveness safety and toxicity of T-DM1
T-DM1 is a specialized antibody targeting HER-2 a protein that is expressed in some breast and salivary gland cancers The drug is a HER-2 antibody that is bound to a chemotherapy agent DM1 and delivered intravenously T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers
The US Food and Drug Administration FDA has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses for breast cancers that express HER2 protein
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
This research study involves radiation chemotherapy and targeted therapy given after surgery for up to 1-year and participants will be followed for 3 years
It is expected that about 55 people will take part in this research study
Genentech is supporting this research study by providing the research study drug T-DM1
This research study is
Studying the use of T-DM1 in combination with radiation and chemotherapy and the use of maintenance T-DM1 alone for up to a year after surgery
Evaluating the effectiveness safety and toxicity of T-DM1
T-DM1 is a specialized antibody targeting HER-2 a protein that is expressed in some breast and salivary gland cancers The drug is a HER-2 antibody that is bound to a chemotherapy agent DM1 and delivered intravenously T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers
The US Food and Drug Administration FDA has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses for breast cancers that express HER2 protein
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
This research study involves radiation chemotherapy and targeted therapy given after surgery for up to 1-year and participants will be followed for 3 years
It is expected that about 55 people will take part in this research study
Genentech is supporting this research study by providing the research study drug T-DM1
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