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NCT04579380 · ClinicalTrials.gov registry record · Phase 2
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
A Phase 2 study of Carcinoma, Non-Small Cell Lung and Urologic Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
- 20
- Study locations
NCT04579380: Active Phase 2 study of Carcinoma, Non-Small Cell Lung and Urologic Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT04579380 is a Phase 2 study of Carcinoma, Non-Small Cell Lung and Urologic Neoplasms that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 217 participants, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04579380, a Phase 2 study of Carcinoma, Non-Small Cell Lung and Urologic Neoplasms, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
Primary Outcome
Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction
Conditions Studied
Interventions
- DRUG fulvestrant
- DRUG tucatinib
- DRUG trastuzumab
Study Locations (20)
California
- City of Hope at Huntington Beach - Huntington Beach
- City of Hope at Irvine Sand Canyon - Irvine
- Koman Family Outpatient Pavilion - La Jolla
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) - La Jolla
- UC San Diego Moores Cancer Center- Investigational Drug Services - La Jolla
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope at Long Beach Worsham - Long Beach
- City of Hope at Long Beach Elm - Long Beach
- City of Hope at Newport Beach Lido - Newport Beach
- City of Hope Torrance - Torrance
Arizona
- HonorHealth - Phoenix
- HonorHealth - Tempe
- The University of Arizona Cancer Center-North Campus - Tucson
Colorado
- Rocky Mountain Cancer Centers - Aurora
- Rocky Mountain Cancer Centers - Boulder
- Rocky Mountain Cancer Centers - Thornton
Minnesota
- Minnesota Oncology Hematology, PA - Coon Rapids
- Metro Minnesota Community Oncology Research Consortium (MMCORC) - Saint Louis Park
Florida
- Moffitt Cancer Center - Tampa
Missouri
- Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices) - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
What the registry record for NCT04579380 still lists
NCT04579380 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (33% lower).
The record links to 6 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which fulvestrant is the first listed.
NCT04579380 names 20 study sites across 6 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04579380 about?
NCT04579380 is a clinical study titled "Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations". This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectab...
What is the current status of trial NCT04579380?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2021-01-11. Estimated completion is 2026-04-30.
What conditions does trial NCT04579380 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Urologic Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Uterine Neoplasms.
What interventions are being tested in trial NCT04579380?
The interventions under investigation include: fulvestrant (DRUG), tucatinib (DRUG), trastuzumab (DRUG).
Who is sponsoring clinical trial NCT04579380?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04579380 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04579380's enrollment target sits among peer trials
217 48th of 130 higher than 83 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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