Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05356897
Status:
WITHDRAWN
Last Update Posted:
2023-10-13
First Post:
2022-04-27
Brief Title:
Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients 3T Study
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
3T a Phase II Single Arm Open Label Study of Tucatinib Combined with Trastuzumab and TAS-102 in Molecularly Selected Patients with HER2 Metastatic Colorectal Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no sites were regulatory ready and the SC took the study to a different group
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies whether tucatinib combined with trastuzumab and TAS-102 works to shrink tumors in patients with HER2 positive colorectal cancer that has spread to other parts of the body metastatic and has one of the following gene mutations detected in blood PIK3CA KRAS NRAS or BRAF V600 Tucatinib is in a class of medications called kinase inhibitors It works by blocking the action of the abnormal protein that signals tumor cells to multiply This helps stop or slow the spread of tumor cells Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules receptors on the surface of tumor cells known as HER2 receptors When trastuzumab attaches to HER2 receptors the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the bodys immune system TAS-102 is a combination of 2 drugs trifluridine and tipiracil Trifluridine is in a class of medications called thymidine-based nucleoside analogues It works by stopping the growth of tumor cells Tipiracil is in a class of medications called thymidine phosphorylase inhibitors It works by slowing the breakdown of trifluridine by the body Giving tucatinib trastuzumab and TAS-102 together may work better than usual treatment for metastatic colorectal cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine the 2-month progression free survival PFS rate of tucatinib trastuzumab and trifluridine and tipiracil hydrochloride TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic colorectal cancer CRC
SECONDARY OBJECTIVES
I To assess the clinical benefit rate CBR stable disease SD for 4 months or best response of complete response CR or partial response PR of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
II To assess the objective response rate ORR of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
III To assess the overall survival OS of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
IV To assess the safety and tolerability of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
CORRELATIVE RESEARCH OBJECTIVES
I To assess whether the combination of tucatinib trastuzumab and TAS-102 eliminates HER2 amplified circulating tumor deoxyribonucleic acid DNA ctDNA from peripheral blood
II To explore the correlation between tissue and blood-based biomarkers and clinical outcomes
OUTLINE
Patients receive tucatinib orally PO twice daily BID trastuzumab intravenously IV over 30-90 minutes on days 1 and 15 and TAS-102 PO BID on days 1-5 and 8-12 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up within 30 days and then every 12 weeks for 4 years after study enrollment
I To determine the 2-month progression free survival PFS rate of tucatinib trastuzumab and trifluridine and tipiracil hydrochloride TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic colorectal cancer CRC
SECONDARY OBJECTIVES
I To assess the clinical benefit rate CBR stable disease SD for 4 months or best response of complete response CR or partial response PR of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
II To assess the objective response rate ORR of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
III To assess the overall survival OS of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
IV To assess the safety and tolerability of tucatinib trastuzumab and TAS-102 in patients with HER2 amplified and PIK3CA RAS andor BRAF mutated metastatic CRC
CORRELATIVE RESEARCH OBJECTIVES
I To assess whether the combination of tucatinib trastuzumab and TAS-102 eliminates HER2 amplified circulating tumor deoxyribonucleic acid DNA ctDNA from peripheral blood
II To explore the correlation between tissue and blood-based biomarkers and clinical outcomes
OUTLINE
Patients receive tucatinib orally PO twice daily BID trastuzumab intravenously IV over 30-90 minutes on days 1 and 15 and TAS-102 PO BID on days 1-5 and 8-12 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up within 30 days and then every 12 weeks for 4 years after study enrollment
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-03147 | REGISTRY | None | None |
| ACCRU-GI-2003 | OTHER | None | None |
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |