A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
Salivary Gland Cancer, Metastatic, Advanced
About this trial
This is an interventional treatment trial for Salivary Gland Cancer focused on measuring molecular profiling, selinexor, tumor tissue
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)
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Unmatched Treatment (Selinexor)
Matched Therapy
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.