A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes (NCT02069730) | Clinical Trial Compass
CompletedNot Applicable
A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
Canada114 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies