Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02069730
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2014-02-20
Brief Title:
A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 is a study of select drug therapies in patients with salivary gland cancer The study has two phases a molecular profiling phase phase 1 and a treatment phase phase 2
Based on the Molecular profiling results in phase the participants will receive matched treatment if a specific aberration is identified or will receive treatment with Selinexor if unmatched and no druggable aberration is identified
Based on the Molecular profiling results in phase the participants will receive matched treatment if a specific aberration is identified or will receive treatment with Selinexor if unmatched and no druggable aberration is identified
Detailed Description:
In molecular profiling phase of the study participants will provide a sample of their tumor tissue to test for changes in certain genes that show whether certain drug treatments will be more useful than others
Once participants have undergone molecular profiling they will be offered a drug treatment depending on the results Certain drug treatments are designed to target certain gene changes If there is a matching drug treatment participants will be offered that treatment either outside a clinical trial or within a clinical trial If there are no gene changes or there are changes to genes were there are no drug treatments available for those certain changes participants will be offered the study drug Selinexor
Cancer is the uncontrolled growth of cells Research shows that one way cancer cells can grow uncontrollably is when certain proteins called exporter proteins are present in high levels in the body These proteins prevent certain other proteins important in protecting cells from becoming cancerous and important in the controlling the growth of cells from working The study drug Selinexor is new class of drug called Selective Inhibitor of Nuclear Export SINE that blocks the exporter proteins from working which may allow the other proteins to work and slow or stop tumors from growing
Once participants have undergone molecular profiling they will be offered a drug treatment depending on the results Certain drug treatments are designed to target certain gene changes If there is a matching drug treatment participants will be offered that treatment either outside a clinical trial or within a clinical trial If there are no gene changes or there are changes to genes were there are no drug treatments available for those certain changes participants will be offered the study drug Selinexor
Cancer is the uncontrolled growth of cells Research shows that one way cancer cells can grow uncontrollably is when certain proteins called exporter proteins are present in high levels in the body These proteins prevent certain other proteins important in protecting cells from becoming cancerous and important in the controlling the growth of cells from working The study drug Selinexor is new class of drug called Selective Inhibitor of Nuclear Export SINE that blocks the exporter proteins from working which may allow the other proteins to work and slow or stop tumors from growing
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