A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes

Official Title

Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms

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.

Trial Description

Primary Outcome:

• Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies

Secondary Outcome:

• Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies
• Length of time that participant's disease does not worsen
• Percentage of each molecular aberrations in metastatic salivary gland tumours

In molecular profiling phase of the study, participants will provide a sample of their tumour 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 tumours from growing.

View this trial on ClinicalTrials.gov