Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487221
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-26
Brief Title:
Avutometinib and Defactinib in Diffuse Gastric Cancer
Sponsor:
Ryan H Moy MD PhD
Organization:
Columbia University
Study Overview
Official Title:
A Phase II Trial of Avutometinib in Combination With Defactinib in Metastatic Diffuse Gastric Cancer
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:
The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants is effective in decreasing the size of the tumors and if it is safe in subjects with diffuse-type stomach cancer
Detailed Description:
There are two main types of stomach cancer based on the appearance under the microscope intestinal-type and diffuse-type Some stomach cancers also have a mix of intestinal-type and diffuse-type mixed type The participants are being invited to take part in this research study due to having been diagnosed with stomach cancer that has spread to other parts of the body andor cannot be surgically removed has diffuse-type or mixed type cells or has gene changes that are associated with diffuse-type stomach cancers such as mutations in the genes called CDH1 or RHOA and have already been treated with chemotherapy and the disease is now growing Defactinib is an oral drug that inhibits the protein focal adhesion kinase FAK which has been shown to promote growth of gastric cancer Avutometinib also known as VS-6766 is an oral drug that blocks an important signaling pathway in cancer cells known as the MAP kinase pathway Avutometinib inhibits two proteins in the MAPK kinase pathway RAF and MEK The purpose of this study is to determine if the combination study treatment with defactinib and avutometinib is effective in improving the length of time after the start of treatment in which a participant is alive and their cancer does not grow or spread
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