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

NCT02069730 | Completed DMC

• 1 other identifier: GEMS-001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic; Advanced; Recurrent; Salivary Gland Cancer

Keywords

molecular profiling; selinexor; tumor tissue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants with complete, partial and/or stable disease to unmatched therapy Selinexor compared to matched therapies

  4 years

• Length of time that participant's disease does not worsen

  6 months

• Percentage of each molecular aberrations in metastatic salivary gland tumors

  4 years

Study Arms (2)

Unmatched Treatment (Selinexor)

EXPERIMENTAL

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

Drug: Selinexor

Matched Therapy

EXPERIMENTAL

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.

Drug: EGFR or HER2 Inhibitor; Drug: FGFR Inhibitor; Drug: C-KIT Inhibitor; Drug: Anti-androgen; Drug: NOTCH Inhibitor; Drug: MEK or PI3K Inhibitor

Interventions

FGFR Inhibitor DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor

Also known as: Matched treatment

Matched Therapy

C-KIT Inhibitor DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor

Also known as: Matched Treatment

Matched Therapy

Anti-androgen DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens

Also known as: Matched Treatment

Matched Therapy

NOTCH Inhibitor DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor

Also known as: Matched Treatment

Matched Therapy

MEK or PI3K Inhibitor DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor

Also known as: Matched Treatment

Matched Therapy

Selinexor DRUG

If no "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive unmatched treatment with Selinexor, a selective inhibitor of nuclear export (SINE).

Also known as: KPT-330

Unmatched Treatment (Selinexor)

EGFR or HER2 Inhibitor DRUG

If specific "druggable" aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with EGFR or HER2 Inhibitor

Also known as: Matched treatment

Matched Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Refuses to have tumor tissue undergo molecular profiling
• Not enough tumor tissue for molecular profiling
• Life expectancy less than 3 months
• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Neoplasm Metastasis; Recurrence; Neoplasms

Interventions

selinexor; Androgen Antagonists; Mitogen-Activated Protein Kinase Kinases

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Protein-Tyrosine Kinases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Anna Spreafico

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 24, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CA (1)