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

Salivary Gland Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02069730
• Other study ID #: GEMS-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Phase 1, Molecular Profiling):

• Have available archival tumor tissue or fresh tumor specimen from diagnostic histological tissue for molecular profiling.
• Histological or cytological proof of malignant salivary gland tumor
• ECOG performance score 0-2
• Documented evidence of recurrent or metastatic disease

Inclusion Criteria (Phase 2, Treatment):

• Interpretable result of molecular profiling in the molecular profiling phase of this study
• Advanced recurrent or metastatic salivary gland cancer for which no curative therapy exists
• Evidence of clinical or radiological disease progression at the time of study treatment
• At least one measurable target lesion as defined by RECIST 1.1
• Must have adequate hematological, liver, renal and cardiac function
• No concomitant use of drugs which may prolong QTc interval
• No history of serious cardiac illness
• No serious medical conditions that might be aggravated by treatment or limit compliance.
• Central nervous system metastases are permitted provided these are clinically stable
• Able to take oral medication and have no evidence of bowel obstruction, infectious/inflammatory bowel disease
• No other active malignancy at any other site
• 18 years of age or older
• Measureable disease as defined by RECIST v1.1
• Not receiving any other concurrent investigational agent
• If the matched treatment is in the context of another phase I trial, the eligibility criteria of the enrolled trial will be used instead of the criteria from this trial

Exclusion Criteria (Phase 1, Molecular Profiling):

• Refuses to have tumor tissue undergo molecular profiling
• Not enough tumor tissue for molecular profiling
• Life expectancy less than 3 months

Exclusion Criteria (Phase 2, Treatment):

• Had stopped the previous treatment but showed no clinical or radiological evidence of disease progression
• Have received the same drug treatment of assignment to the specific arm before the enrolment in to treatment phase (phase 2)

Related Conditions & MeSH terms

• Advanced
• Metastatic
• Recurrent
• Salivary Gland Cancer
• Salivary Gland Neoplasms

Intervention

Drug:
• Selinexor
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).
• EGFR or HER2 Inhibitor
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with EGFR or HER2 Inhibitor
• FGFR Inhibitor
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor
• C-KIT Inhibitor
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor
• Anti-androgen
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens
• NOTCH Inhibitor
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor
• MEK or PI3K Inhibitor
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Length of time that participant's disease does not worsen	Progression free survival rate in the setting of matched and unmatched therapy.	6 months
Secondary	Percentage of each molecular aberrations in metastatic salivary gland tumors	Molecular profiling results in malignant salivary gland tumor	4 years