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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 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Salivary Gland Cancer Metastatic Advanced Recurrent Drug: Selinexor Drug: EGFR or HER2 Inhibitor Drug: FGFR Inhibitor Drug: C-KIT Inhibitor Drug: Anti-androgen Drug: NOTCH Inhibitor Drug: MEK or PI3K Inhibitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms
Study Start Date : June 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unmatched Treatment (Selinexor)
Selinexor, 30mg/m2, by mouth, twice weekly, every 28 day cycles.
Drug: Selinexor
Other Name: KPT-330

Experimental: Unmatched Therapy
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.
Drug: EGFR or HER2 Inhibitor
Drug: FGFR Inhibitor
Drug: C-KIT Inhibitor
Drug: Anti-androgen
Drug: NOTCH Inhibitor
Drug: MEK or PI3K Inhibitor



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

Secondary Outcome Measures :
  1. Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies [ Time Frame: 4 years ]
  2. Length of time that participant's disease does not worsen [ Time Frame: 6 months ]
  3. Percentage of each molecular aberrations in metastatic salivary gland tumors [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069730


Contacts
Contact: AARON HANSEN 416-946-4501 ext 5606

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: AARON HANSEN, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: AARON HANSEN, M.D. Princess Margaret Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02069730     History of Changes
Other Study ID Numbers: GEMS-001
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by University Health Network, Toronto:
molecular profiling
selinexor
tumor tissue

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Androgens
Androgen Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists