Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

NCT04499924 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 17 participants
Start Date 2021-03-22
Est. Completion 2024-04-17
Phase Phase 2

Sponsor

Seagen

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04499924

The ClinicalTrials.gov registry entry for NCT04499924 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04499924 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Colorado, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04499924?

The interventions under investigation include: tucatinib (DRUG), trastuzumab (DRUG), paclitaxel (DRUG), ramucirumab (DRUG), tucatinib placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04499924?

This trial is sponsored by Seagen, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial