Salivary Gland Cancer Clinical Trial
Official title:
Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms
Verified date | January 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 114 |
Est. completion date | December 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 years | |
Secondary | 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. | 4 years | |
Secondary | Length of time that participant's disease does not worsen | Progression free survival rate in the setting of matched and unmatched therapy. | 6 months | |
Secondary | Percentage of each molecular aberrations in metastatic salivary gland tumors | Molecular profiling results in malignant salivary gland tumor | 4 years |
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