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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unmatched Treatment (Selinexor) | Experimental | Selinexor, 30mg/m2, by mouth, twice weekly, every 28 day cycles. If patients have a "druggable" aberration but there is no access to the relevant agent, then patients will receive selinexor |
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| Matched Therapy | Experimental | EGFR or HER2 Inhibitor,FGFR Inhibitor,C-KIT Inhibitor, Anti-androgen ,NOTCH Inhibitor,MEK or PI3K Inhibitor . If the matched therapy is given through a clinical trial, the dosing schedule will be determined by that particular trial protocol. For matched treatments administered outside of a clinical trial, the dosing schedule will be the recommended dose by the expertise of the treating investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | If no "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive unmatched treatment with Selinexor, a selective inhibitor of nuclear export (SINE). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies | Overall Response rate in the setting of matched and unmatched therapy. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies | Disease control Rate in the setting of matched and unmatched therapy. | 4 years |
| Length of time that participant's disease does not worsen |
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Inclusion Criteria (Phase 1, Molecular Profiling):
Inclusion Criteria (Phase 2, Treatment):
Exclusion Criteria (Phase 1, Molecular Profiling):
Exclusion Criteria (Phase 2, Treatment):
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| Name | Affiliation | Role |
|---|---|---|
| Anna Spreafico | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
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| EGFR or HER2 Inhibitor | Drug | If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with EGFR or HER2 Inhibitor |
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| FGFR Inhibitor | Drug | If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor |
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| C-KIT Inhibitor | Drug | If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor |
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| Anti-androgen | Drug | If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens |
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| NOTCH Inhibitor | Drug | If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor |
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| MEK or PI3K Inhibitor | Drug | If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor |
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Progression free survival rate in the setting of matched and unmatched therapy. |
| 6 months |
| Percentage of each molecular aberrations in metastatic salivary gland tumors | Molecular profiling results in malignant salivary gland tumor | 4 years |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C585161 | selinexor |
| D000726 | Androgen Antagonists |
| D020929 | Mitogen-Activated Protein Kinase Kinases |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D017346 | Protein Serine-Threonine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011505 | Protein-Tyrosine Kinases |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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