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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies