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NCT04499924 · ClinicalTrials.gov registry record · Phase 2
Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
A Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by Seagen.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 20
- Study locations
NCT04499924: Completed Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by Seagen.
NCT04499924 is a Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma that has completed, run by Seagen. The registered enrollment target is 17 participants, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04499924, a Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
DLTs were adverse events (AEs), laboratory abnormalities, or treatment modifications that occurred during the first cycle of treatment in the Phase 2 paclitaxel dose optimization stage that were related to paclitaxel, to tucatinib, or to the combination of tucatinib, trastuzumab, ramucirumab and paclitaxel and that met any of the study protocol specified criteria. The relationship of AEs to study drugs was determined by the investigator. AEs that were attributed only to trastuzumab and/or ramuci
Conditions Studied
Interventions
- DRUG tucatinib
- DRUG trastuzumab
- DRUG paclitaxel
- DRUG ramucirumab
- OTHER tucatinib placebo
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
- Cancer Centers of Colorado - Denver - Denver
- SCL Health - St. Mary's Hospital & Medical Center - Grand Junction
- SCL Health Good Samaritan Medical Center Cancer Centers of Colorado - Lafayette
- Lutheran Medical Center - Cancer Centers of Colorado - Wheat Ridge
Arizona
- Mayo Clinic Arizona - Phoenix
- Arizona Cancer Center / University of Arizona - Tucson
California
- City of Hope National Medical Center - Duarte
- UCLA Medical Center / David Geffen School of Medicine - Santa Monica
Alabama
- University of Alabama at Birmingham - Birmingham
District of Columbia
- Lombardi Cancer Center / Georgetown University Medical Center - Washington D.C.
Illinois
- University of Chicago Medical Center - Chicago
Iowa
- Holden Comprehensive Cancer Center / University of Iowa - Iowa City
Kentucky
- Norton Cancer Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 2 |
What the finished NCT04499924 record still lists
NCT04499924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which tucatinib is the first listed.
NCT04499924 names 20 study sites across 14 states, led by Colorado, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04499924 about?
NCT04499924 is a clinical study titled "Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer". 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 t...
What is the current status of trial NCT04499924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2021-03-22. Estimated completion is 2024-04-17.
What conditions does trial NCT04499924 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT04499924?
The interventions under investigation include: tucatinib (DRUG), trastuzumab (DRUG), paclitaxel (DRUG), ramucirumab (DRUG), tucatinib placebo (OTHER).
Who is sponsoring clinical trial NCT04499924?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04499924 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04499924's enrollment target sits among peer trials
17 45th of 47 higher than 3 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Adenocarcinoma 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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