A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
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|ClinicalTrials.gov Identifier: NCT02069730|
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : February 8, 2017
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Salivary Gland Cancer Metastatic Advanced Recurrent||Drug: Selinexor Drug: EGFR or HER2 Inhibitor Drug: FGFR Inhibitor Drug: C-KIT Inhibitor Drug: Anti-androgen Drug: NOTCH Inhibitor Drug: MEK or PI3K Inhibitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Unmatched Treatment (Selinexor)
Selinexor, 30mg/m2, by mouth, twice weekly, every 28 day cycles.
Other Name: KPT-330
Experimental: Unmatched Therapy
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.
Drug: EGFR or HER2 Inhibitor
Drug: FGFR Inhibitor
Drug: C-KIT Inhibitor
Drug: NOTCH Inhibitor
Drug: MEK or PI3K Inhibitor
- Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies [ Time Frame: 4 years ]
- Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies [ Time Frame: 4 years ]
- Length of time that participant's disease does not worsen [ Time Frame: 6 months ]
- Percentage of each molecular aberrations in metastatic salivary gland tumors [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069730
|Contact: AARON HANSEN||416-946-4501 ext 5606|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: AARON HANSEN, M.D.|
|Principal Investigator:||AARON HANSEN, M.D.||Princess Margaret Cancer Centre|