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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS)

Secondary outcome measures

Duration Of Response (DOR)

Incidence of Adverse Events

Objective Response Rate (ORR)

+3 more

Other outcome measures

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

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,736 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,252 Total Patients Enrolled

Alan L HoPrincipal InvestigatorNRG Oncology

3 Previous Clinical Trials

114 Total Patients Enrolled

Media Library

Docetaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05408845 — Phase 2

Salivary Gland Cancer Research Study Groups: Arm I (docetaxel, trastuzumab), Arm II (trastuzumab emtansine)

Salivary Gland Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT05408845 — Phase 2

Docetaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408845 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA accorded Arm II (trastuzumab emtansine) permission to be utilized?

"Taking into account the Phase 2 trial data, our team at Power judged Arm II (trastuzumab emtansine) to be safe enough for a score of 2. However, there is not yet sufficient evidence to support its efficacy."

Answered by AI

What is the maximum capacity of participants accepted in this medical study?

"Affirmative. The evidence on clinicaltrials.gov indicates that the medical trial is actively recruiting volunteers, having first been posted on September 30th 2022 and last edited on January 11 2023. 116 participants are required for this single-site study."

Answered by AI

What goals is the clinical trial aiming to achieve?

"The primary endpoint of this trial is Progression Free Survival (PFS), which will be evaluated over a 5 year period from randomization until either disease progression or death due to any cause, whichever occurs first. After 98 PFS events have been reported, an analysis will take place. Secondary outcomes include Treatment Discontinuations Due to AEs, Patient-Reported Toxicity and Incidence of Adverse Events; all comparisons between treatment arms are tested using chi-Square tests with 10% two-sided significance levels. This has the potential to detect differences in proportions such as Arm 2's 0.15 versus Arm 1's 0."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer

2022. "Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408845.

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