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Anti-tumor antibiotic

Trastuzumab Emtansine for Salivary Gland Cancer

Phase 2

Recruiting

Led By Alan L Ho

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

Age >= 18

Patients with unresectable disease who are not candidates for curative surgery or radiation OR recurrent OR metastatic disease

Must not have

Exposure to cumulative doses of anthracyclines

Interstitial lung disease or pulmonary fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to disease progression or death due to any cause, whichever occurs first. analysis occurs after 98 pfs events have been reported, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trialtests a drug to shrink tumors in patients with HER2+ recurrent, metastatic, or unresectable salivary gland cancer.

Who is the study for?

Adults with HER2-positive salivary gland cancer that's recurrent, metastatic, or can't be surgically removed. Must have adequate organ function and agree to use effective contraception. Excludes those who've had systemic therapy for this cancer stage, certain severe health conditions, active infections requiring IV antibiotics, specific heart diseases, or untreated brain metastases.

What is being tested?

The trial is testing ado-trastuzumab emtansine (a targeted antibody linked to chemo) against the usual treatment of docetaxel plus trastuzumab in shrinking tumors. It aims to see if this new approach is more effective for patients with advanced HER2-positive salivary gland cancer.

What are the potential side effects?

Potential side effects include allergic reactions similar to those from components of ado-trastuzumab emtansine or docetaxel; issues like bleeding events; nerve damage; lung problems such as pneumonitis; and heart complications due to past anthracycline use.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer cannot be removed by surgery, has come back, or has spread.

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My salivary gland cancer is HER2 positive.

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I had hepatitis C but have been successfully treated and cured.

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I am HIV positive, on treatment, and my viral load is undetectable.

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My kidney function is within the required range.

Exclusion Criteria

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

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I have been treated with anthracyclines before.

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I have a lung condition involving scarring or fibrosis.

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I am not pregnant and willing to stop nursing.

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I have not had severe bleeding in the last 28 days.

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I have had treatment for cancer that could not be surgically removed or has spread.

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I am currently on IV antibiotics for an infection.

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I have severe nerve damage in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to disease progression or death due to any cause, whichever occurs first. analysis occurs after 98 pfs events have been reported, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to disease progression or death due to any cause, whichever occurs first. analysis occurs after 98 pfs events have been reported, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to disease progression or death due to any cause, whichever occurs first. analysis occurs after 98 pfs events have been reported, assessed up to 5 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

Progression-Free Survival (PFS)

Secondary study objectives

Duration Of Response (DOR)

Incidence of Adverse Events

Objective Response Rate (ORR)

+3 more

Other study objectives

Objective Response Rate (ORR) for patients who receive crossover treatment to T-DM1/TH following disease progression on the TH/T-DM1 arm

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

Active Control

Group I: Arm II (trastuzumab emtansine)Experimental Treatment2 Interventions

Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (docetaxel, trastuzumab)Active Control3 Interventions

Patients receive docetaxel IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab Emtansine

2016

Completed Phase 3

~5630

0 / 13Eligibility criteria met