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

NCT ID: NCT02069730

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Salivary Gland Cancer; Metastatic; Advanced; Recurrent

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unmatched Treatment (Selinexor)

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

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: 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).

Matched Therapy

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.

Group Type: EXPERIMENTAL

EGFR or HER2 Inhibitor

Intervention Type: DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with EGFR or HER2 Inhibitor

FGFR Inhibitor

Intervention Type: DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor

C-KIT Inhibitor

Intervention Type: DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor

Anti-androgen

Intervention Type: DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens

NOTCH Inhibitor

Intervention Type: DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor

MEK or PI3K Inhibitor

Intervention Type: DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor

Interventions

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).

Intervention Type: DRUG

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

Intervention Type: DRUG

FGFR Inhibitor

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor

Intervention Type: DRUG

C-KIT Inhibitor

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor

Intervention Type: DRUG

Anti-androgen

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens

Intervention Type: DRUG

NOTCH Inhibitor

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

KPT-330; Matched treatment; Matched treatment; Matched Treatment; Matched Treatment; Matched Treatment; Matched Treatment

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Spreafico

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

GEMS-001

Identifier Type: -

Identifier Source: org_study_id