Clinical trial · Interventional
A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes
Genomic Profiling and Matched Therapy for Recurrent or Metastatic Salivary Gland Neoplasms
NCT02069730CI-TRIAL-00100477completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced | — | UNRESOLVED | — |
| Metastatic | Salivary Gland Neoplasm | PROBABILISTIC | 0.70 |
| Recurrent | — | UNRESOLVED | — |
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-androgen | Drug | — | UNRESOLVED |
| C-KIT Inhibitor | Drug | — | UNRESOLVED |
| EGFR or HER2 Inhibitor | Drug | — | UNRESOLVED |
| FGFR Inhibitor | Drug | — | UNRESOLVED |
| MEK or PI3K Inhibitor | Drug | — | UNRESOLVED |
| NOTCH Inhibitor | Drug | — | UNRESOLVED |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Unmatched Treatment (Selinexor)
- description
- 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
- interventionNames
- Drug: Selinexor
- type
- EXPERIMENTAL
- label
- Matched Therapy
- description
- 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.
- interventionNames
- Drug: EGFR or HER2 Inhibitor
- Drug: FGFR Inhibitor
- Drug: C-KIT Inhibitor
- Drug: Anti-androgen
- Drug: NOTCH Inhibitor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.