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NCT04439110 · ClinicalTrials.gov registry record · Phase 2
Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)
A Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04439110: Active Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by National Cancer Institute (NCI).
NCT04439110 is a Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04439110, a Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II MATCH treatment trial identifies the effects of ado-trastuzumab emtansine in patients whose cancer has a genetic change called HER2 amplification. Ado-trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. 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 and delivers DM1 to kill them. Researchers hope to learn if the study drug will shrink this type of cancer or stop its growth.
Primary Outcome
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR.
Conditions Studied
Interventions
- BIOLOGICAL Trastuzumab Emtansine
Study Locations (1)
Pennsylvania
- ECOG-ACRIN Cancer Research Group - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-08-12 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
What the registry record for NCT04439110 still lists
NCT04439110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (78% lower).
The record links to 6 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab Emtansine is the first listed.
NCT04439110 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04439110 about?
NCT04439110 is a clinical study titled "Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)". This phase II MATCH treatment trial identifies the effects of ado-trastuzumab emtansine in patients whose cancer has a genetic change called HER2 amplification. Ado-trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab is a form of ...
What is the current status of trial NCT04439110?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2015-08-12. Estimated completion is 2026-03-19.
What conditions does trial NCT04439110 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Multiple Myeloma, Refractory Malignant Solid Neoplasm, Refractory Lymphoma.
What interventions are being tested in trial NCT04439110?
The interventions under investigation include: Trastuzumab Emtansine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04439110?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04439110 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04439110's enrollment target sits among peer trials
38 66th of 108 higher than 42 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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