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

Sponsor
University Health Network, Toronto
Study ID
NCT02069730
Status
Completed

Conditions

  • Advanced
  • Metastatic
  • Recurrent
  • Salivary Gland Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2014
Status verified
Jan 2026
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
114 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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.

Primary Outcome Measure

Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies [ Time Frame: 4 years ]

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