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

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ClinicalTrials.gov Identifier: NCT02069730
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE February 24, 2014
Last Update Posted Date February 5, 2019
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02069730 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
  • Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies [ Time Frame: 4 years ]
  • Length of time that participant's disease does not worsen [ Time Frame: 6 months ]
  • Percentage of each molecular aberrations in metastatic salivary gland tumors [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
Official Title  ICMJE Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms
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).

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Salivary Gland Cancer
  • Metastatic
  • Advanced
  • Recurrent
Intervention  ICMJE
  • Drug: Selinexor
    Other Name: KPT-330
  • Drug: EGFR or HER2 Inhibitor
  • Drug: FGFR Inhibitor
  • Drug: C-KIT Inhibitor
  • Drug: Anti-androgen
  • Drug: NOTCH Inhibitor
  • Drug: MEK or PI3K Inhibitor
Study Arms  ICMJE
  • 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

    Intervention: Drug: 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.

    Interventions:
    • Drug: EGFR or HER2 Inhibitor
    • Drug: FGFR Inhibitor
    • Drug: C-KIT Inhibitor
    • Drug: Anti-androgen
    • Drug: NOTCH Inhibitor
    • Drug: MEK or PI3K Inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AARON HANSEN 416-946-4501 ext 5606
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02069730
Other Study ID Numbers  ICMJE GEMS-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AARON HANSEN, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP