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NCT04639219 · ClinicalTrials.gov registry record · Phase 2
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
A Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT04639219 is a Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 102 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT04639219, a Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.
Conditions Studied
Interventions
- DRUG Trastuzumab deruxtecan
Study Locations (20)
Other
- Research Site - Anderlecht
- Research Site - Copenhagen
- Research Site - Bordeaux
- Research Site - Lyon
- Research Site - Villejuif
- Research Site - Milan
- Research Site - Milan
- Research Site - Naples
- Research Site - Chūōku
New York
- Research Site - Commack
- Research Site - Harrison
- Research Site - New York
Massachusetts
- Research Site - Boston
- Research Site - Boston
California
- Research Site - Santa Rosa
Indiana
- Research Site - Muncie
New Jersey
- Research Site - Middletown
Texas
- Research Site - Houston
Virginia
- Research Site - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2026-07-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04639219
The ClinicalTrials.gov registry entry for NCT04639219 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab deruxtecan is the first listed.
NCT04639219 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04639219 about?
NCT04639219 is a clinical study titled "A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations". This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progre...
What is the current status of trial NCT04639219?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2020-12-30. Estimated completion is 2026-07-14.
What conditions does trial NCT04639219 study?
This clinical trial studies the following conditions: Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast.
What interventions are being tested in trial NCT04639219?
The interventions under investigation include: Trastuzumab deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04639219?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04639219 being conducted?
This trial has 20 study locations across California, Indiana, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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