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

Primary Purpose

Salivary Gland Cancer, Metastatic, Advanced

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Selinexor
EGFR or HER2 Inhibitor
FGFR Inhibitor
C-KIT Inhibitor
Anti-androgen
NOTCH Inhibitor
MEK or PI3K Inhibitor
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Salivary Gland Cancer focused on measuring molecular profiling, selinexor, tumor tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Princess Margaret Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unmatched Treatment (Selinexor)

Matched Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2014
Last Updated
September 19, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02069730
Brief Title
A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
Official Title
Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Cancer, Metastatic, Advanced, Recurrent
Keywords
molecular profiling, selinexor, tumor tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unmatched Treatment (Selinexor)
Arm Type
Experimental
Arm Description
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
Arm Title
Matched Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
KPT-330
Intervention Description
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
Intervention Name(s)
EGFR or HER2 Inhibitor
Other Intervention Name(s)
Matched treatment
Intervention Description
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
Intervention Name(s)
FGFR Inhibitor
Other Intervention Name(s)
Matched treatment
Intervention Description
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor
Intervention Type
Drug
Intervention Name(s)
C-KIT Inhibitor
Other Intervention Name(s)
Matched Treatment
Intervention Description
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor
Intervention Type
Drug
Intervention Name(s)
Anti-androgen
Other Intervention Name(s)
Matched Treatment
Intervention Description
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens
Intervention Type
Drug
Intervention Name(s)
NOTCH Inhibitor
Other Intervention Name(s)
Matched Treatment
Intervention Description
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor
Intervention Type
Drug
Intervention Name(s)
MEK or PI3K Inhibitor
Other Intervention Name(s)
Matched Treatment
Intervention Description
If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor
Primary Outcome Measure Information:
Title
Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies
Description
Overall Response rate in the setting of matched and unmatched therapy.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies
Description
Disease control Rate in the setting of matched and unmatched therapy.
Time Frame
4 years
Title
Length of time that participant's disease does not worsen
Description
Progression free survival rate in the setting of matched and unmatched therapy.
Time Frame
6 months
Title
Percentage of each molecular aberrations in metastatic salivary gland tumors
Description
Molecular profiling results in malignant salivary gland tumor
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Spreafico
Phone
416-946-4501
Ext
5083
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Spreafico
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Spreafico, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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