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

• Status: Recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Androgen Antagonists; Androgens

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)