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NCT05408845 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
A Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
- 20
- Study locations
NCT05408845 is a Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 146 participants, above the 106-participant average among 5 other Recurrent Salivary Gland Carcinoma trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 2 states.
The verdict
NCT05408845, a Phase 2 study of Recurrent Salivary Gland Carcinoma and Metastatic Salivary Gland Carcinoma, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- Kaiser Permanente-Fresno - Fresno
- City of Hope at Irvine Lennar - Irvine
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Stanford Cancer Institute Palo Alto - Palo Alto
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente Downtown Commons - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser San Rafael-Gallinas - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- Kaiser Permanente-Santa Rosa - Santa Rosa
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05408845
The ClinicalTrials.gov registry entry for NCT05408845 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 106-participant average among 5 other Recurrent Salivary Gland Carcinoma trials with a reported enrollment target (38% higher). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Recurrent Salivary Gland Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05408845 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05408845 about?
NCT05408845 is a clinical study titled "Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers". This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, ...
What is the current status of trial NCT05408845?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2023-03-03. Estimated completion is 2028-07-31.
What conditions does trial NCT05408845 study?
This clinical trial studies the following conditions: Recurrent Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Stage IV Major Salivary Gland Cancer AJCC v8, Unresectable Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8.
What interventions are being tested in trial NCT05408845?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT05408845?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05408845 being conducted?
This trial has 20 study locations across Alabama, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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