Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
Public ClinicalTrials.gov record NCT04499924. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Active Comparator Phase 2/3 Study of Tucatinib in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Subjects With Previously Treated, Locally-advanced Unresectable or Metastatic HER2+ Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. Study treatment will be given in 28-day cycles. In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.
Study identification
- NCT ID
- NCT04499924
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 17 participants
Conditions and interventions
Conditions
Interventions
- tucatinib Drug
- trastuzumab Drug
- ramucirumab Drug
- paclitaxel Drug
- tucatinib placebo Other
- trastuzumab placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 22, 2021 (Actual)
- Primary completion
- Apr 17, 2024 (Actual)
- Completion
- Apr 17, 2024 (Actual)
- Last update posted
- Jan 22, 2025
2021 – 2024
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Arizona Cancer Center / University of Arizona | Tucson | Arizona | 85724 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| UCLA Medical Center / David Geffen School of Medicine | Santa Monica | California | 90404 | — |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | — |
| Cancer Centers of Colorado - Denver | Denver | Colorado | 80218 | — |
| SCL Health - St. Mary's Hospital & Medical Center | Grand Junction | Colorado | 81501 | — |
| SCL Health Good Samaritan Medical Center Cancer Centers of Colorado | Lafayette | Colorado | 80026 | — |
| Lutheran Medical Center - Cancer Centers of Colorado | Wheat Ridge | Colorado | 80033 | — |
| Lombardi Cancer Center / Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Holden Comprehensive Cancer Center / University of Iowa | Iowa City | Iowa | 52242 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40217 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Minnesota Oncology Hematology P.A. | Saint Paul | Minnesota | 55102 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic - Taussig Cancer Institute | Cleveland | Ohio | 44195 | — |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | — |
| University of Pennsylvania / Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Tennessee | Knoxville | Tennessee | 37920 | — |
| Tennessee Oncology-Nashville/Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Baylor Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78217 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04499924, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04499924 live on ClinicalTrials.gov.