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Anti-androgen

Targeted Therapy for Salivary Gland Cancer

N/A

Waitlist Available

Led By AARON HANSEN, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

(Phase 1, Molecular Profiling) Histological or cytological proof of malignant salivary gland tumor

(Phase 2, Treatment) Evidence of clinical or radiological disease progression at the time of study treatment

Must not have

(Phase 1, Molecular Profiling) Not enough tumor tissue for molecular profiling

(Phase 2, Treatment) Have received the same drug treatment of assignment to the specific arm before the enrolment in to treatment phase (phase 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if certain drugs can help treat salivary gland cancer. In the first phase, doctors will see what kind of cancer the patient has. In the second phase, the patient will receive a matched treatment if their cancer has a specific aberration. If not, the patient will receive Selinexor.

Who is the study for?

This trial is for adults with advanced salivary gland cancer that has returned or spread, and there's no cure available. Participants need to have a measurable tumor, good heart and organ function, and no serious heart issues or drugs affecting their heartbeat. They must show disease progression and provide tissue samples for gene testing.

What is being tested?

The study tests various drug therapies tailored to genetic abnormalities in salivary gland cancers. If specific gene changes are found, patients get matched treatments; otherwise, they receive Selinexor. It includes initial gene profiling followed by treatment based on the results.

What are the potential side effects?

Potential side effects may include skin rash, high blood pressure from MEK/PI3K inhibitors; fatigue and mood changes from anti-androgens; nausea from C-KIT inhibitors; weight loss from Selinexor; diarrhea from EGFR/HER2 inhibitors; mouth sores from FGFR inhibitors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis of a salivary gland tumor was confirmed through testing.

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My cancer is getting worse as shown by tests or how I feel.

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I can take pills and don't have bowel blockage or inflammatory bowel disease.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer has come back or spread to other parts.

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My salivary gland cancer has returned or spread and cannot be cured.

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I am not taking any medications that can affect my heart's rhythm.

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I have no history of serious heart problems.

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I do not have any other active cancer.

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I am 18 years old or older.

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My cancer can be measured by standard health scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor does not have enough tissue for detailed genetic testing.

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I have previously received the same drug that I will be assigned in phase 2.

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My doctor expects I have less than 3 months to live.

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I refuse to have my tumor tissue tested for genetic changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with complete and partial response to unmatched therapy Selinexor compared to matched therapies

Secondary study objectives

Length of time that participant's disease does not worsen

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

Percentage of each molecular aberrations in metastatic salivary gland tumors

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

50%

Thrombocytopenia

45%

Anaemia

39%

Nausea

29%

Decreased appetite

29%

Diarrhoea

27%

Weight decreased

24%

Neuropathy peripheral

24%

Vomiting

23%

Fatigue

21%

Neutropenia

21%

Cataract

15%

Asthenia

12%

Upper respiratory tract infection

11%

Pyrexia

11%

Constipation

Oedema peripheral

Pneumonia

Lymphopenia

Dizziness

Insomnia

Dehydration

Back pain

Leukopenia

Bronchitis

Cough

Acute kidney injury

Abdominal pain

Muscular weakness

Lower respiratory tract infection

Pain in extremity

Sepsis

Hyperglycaemia

Urinary tract infection

Nasopharyngitis

Hyponatraemia

Toothache

Disturbance in attention

Cardiac failure

Hypertension

Blood uric acid increased

Cardiac failure acute

Pulmonary contusion

Peripheral swelling

Blood creatinine increased

Paraesthesia

Infection

Respiratory syncytial virus infection

Dyspepsia

Syncope

Clostridium difficile infection

Compression fracture

Multiple fractures

Myocardial infarction

C-reactive protein increased

Cerebral haemorrhage

Ischaemic stroke

Sudden death

Oropharyngeal pain

Cognitive disorder

Confusional state

Influenza

Septic shock

Osteonecrosis of jaw

Taste disorder

Hyperkalaemia

Depression

Cerebrovascular accident

Bronchitis viral

Embolism

Haemoglobin decreased

100%

80%

60%

40%

20%

Study treatment Arm

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SdX Arm: Selinexor + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Unmatched Treatment (Selinexor)Experimental Treatment1 Intervention

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

Group II: Matched TherapyExperimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

2020

Completed Phase 3

~1730

0 / 15Eligibility criteria met