Salivary Gland CancerNCT02069730

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

A study testing Selinexor, EGFR or HER2 Inhibitor and FGFR Inhibitor in people with Salivary Gland Cancer and Metastatic, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Salivary Gland Cancer, Metastatic, Advanced
What is being tested?: Selinexor, EGFR or HER2 Inhibitor and FGFR Inhibitor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteCanada
Study dates: Jun 2014to Jun 2023
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 19Show fewer

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the 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
Being tested: Selinexor, EGFR or HER2 Inhibitor, FGFR Inhibitor, C-KIT Inhibitor, Anti-androgen
Keywords: molecular profiling, selinexor, tumor tissue
Medical subject headings: Salivary Gland Neoplasms, Neoplasm Metastasis, Recurrence, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelinexorDrug
Also called KPT-330
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 InhibitorDrug
Also called Matched treatment
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with EGFR or HER2 Inhibitor
FGFR InhibitorDrug
Also called Matched treatment
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor
C-KIT InhibitorDrug
Also called Matched Treatment
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor
Anti-androgenDrug
Also called Matched Treatment
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens
NOTCH InhibitorDrug
Also called Matched Treatment
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor
MEK or PI3K InhibitorDrug
Also called Matched Treatment
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor

Study groups in NCT02069730
Study group	Role	What they receive
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 Receives: Drug: Selinexor
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. Receives: Drug: EGFR or HER2 Inhibitor; Drug: FGFR Inhibitor; Drug: C-KIT Inhibitor; Drug: Anti-androgen; Drug: NOTCH Inhibitor; Drug: MEK or PI3K Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 years

Secondary outcomes (3)

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.
Measured: 4 years
Length of time that participant's disease does not worsen
Progression free survival rate in the setting of matched and unmatched therapy.
Measured: 6 months
Percentage of each molecular aberrations in metastatic salivary gland tumors
Molecular profiling results in malignant salivary gland tumor
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jun 2023

First posted24 Feb 2014 (estimated)
Study startJun 2014
Primary completionJun 2023
Study completionJun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Salivary Gland CancerStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02069730
Sponsor's protocol ID: GEMS-001
Status last verified: Jan 2026
First submitted: 20 Feb 2014
Last updated: 8 Jan 2026
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
Salivary Gland Cancer, Recurrent Salivary Gland Cancer
RecruitingPhase 2
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 3
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma
Active, not recruitingPhase 2
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Head and Neck Cancer

All Salivary Gland Cancer trials