Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05673928
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2022-12-30
Brief Title:
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine T-DM1 in Patients with HER2-positive Metastatic Solid Tumors and Metastases to Brain TUCATEMEB
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine T-DM1 in Patients with HER2-positive Metastatic Solid Tumors and Metastases to Brain TUCATEMEB
Status:
RECRUITING
Status Verified Date:
2024-09
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:
To learn if the study drugs tucatinib and adotrastuzumab emtansine T-DM1 can help to control solid tumors that have spread to the brain
Detailed Description:
Primary Objectives
To determine the intracranial antitumor activity of the tucatinib and ado-trastuzumab emtansine T- bination per the modified Response Evaluation Criteria in Solid Tumors mRECIST in patients with huma
Key Secondary Objectives
To determine the intracranial antitumor activity of the tucatinib and T-DM1 combination per the Response Assessment in Neuro-Oncology Brain Metastases RANO-BM criteria in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate the duration of intracranial response of the tucatinib and T-DM1 combination in patients with HER2-positive metastatic solid tumors and brain metastases
Other Secondary Objectives
To evaluate the safety and tolerability of the tucatinib and T-DM1 combination in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate the systemic antitumor activity of the tucatinib and T-DM1 combination per the Response Evaluation Criteria in Solid Tumors RECIST v11 in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate progression-free survival PFS in patients with HER2-positive metastatic solid tumors and brain metastases receiving the tucatinib and T-DM1 combination
To evaluate overall survival OS in patients with HER2-positive metastatic solid tumors and brain metastases receiving the tucatinib and T-DM1 combination
To evaluate the duration of response to the tucatinib and T-DM1 combination per the RECIST v11 in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate the clinical benefit rate of the tucatinib and T-DM1 combination per the RECIST v11 in patients with HER2-positive metastatic solid tumors and brain metastases
Exploratory Objectives
To assess the effects of the tucatinib and T-DM1 combination on cell proliferation and apoptosis
To evaluate predictive and pharmacodynamic PD biomarkers of response and resistance to the tucatinib and T-DM1 combination
To assess the effects of the tucatinib and T-DM1 combination on circulating-free DNA cfDNA dynamics
To determine the intracranial antitumor activity of the tucatinib and ado-trastuzumab emtansine T- bination per the modified Response Evaluation Criteria in Solid Tumors mRECIST in patients with huma
Key Secondary Objectives
To determine the intracranial antitumor activity of the tucatinib and T-DM1 combination per the Response Assessment in Neuro-Oncology Brain Metastases RANO-BM criteria in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate the duration of intracranial response of the tucatinib and T-DM1 combination in patients with HER2-positive metastatic solid tumors and brain metastases
Other Secondary Objectives
To evaluate the safety and tolerability of the tucatinib and T-DM1 combination in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate the systemic antitumor activity of the tucatinib and T-DM1 combination per the Response Evaluation Criteria in Solid Tumors RECIST v11 in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate progression-free survival PFS in patients with HER2-positive metastatic solid tumors and brain metastases receiving the tucatinib and T-DM1 combination
To evaluate overall survival OS in patients with HER2-positive metastatic solid tumors and brain metastases receiving the tucatinib and T-DM1 combination
To evaluate the duration of response to the tucatinib and T-DM1 combination per the RECIST v11 in patients with HER2-positive metastatic solid tumors and brain metastases
To evaluate the clinical benefit rate of the tucatinib and T-DM1 combination per the RECIST v11 in patients with HER2-positive metastatic solid tumors and brain metastases
Exploratory Objectives
To assess the effects of the tucatinib and T-DM1 combination on cell proliferation and apoptosis
To evaluate predictive and pharmacodynamic PD biomarkers of response and resistance to the tucatinib and T-DM1 combination
To assess the effects of the tucatinib and T-DM1 combination on circulating-free DNA cfDNA dynamics
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-11157 | OTHER | NCI-CTRP Clinical Trials Registry | None |