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ACTIVE NOT RECRUITING Phase 2

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

NCT04430738 · View on ClinicalTrials.gov ↗

Study Summary

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will 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. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

Interventions

  • DRUG tucatinib
  • DRUG trastuzumab
  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin

Study Locations (20)

Missouri

  • Siteman Cancer Center - St Peters — City of Saint Peters
  • Siteman Cancer Center - West County — Creve Coeur
  • Siteman Cancer Center - North County — Florissant
  • Siteman Cancer Center — St Louis
  • Barnes-Jewish Hospital — St Louis
  • Washington University School of Medicine — St Louis
  • Siteman Cancer Center - South County — St Louis

Colorado

  • University of Colorado Denver CTO(CTRC) — Aurora
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora
  • PCM Trials — Denver

Arizona

  • Mayo Clinic Hospital — Phoenix
  • Mayo Clinic — Scottsdale

North Carolina

  • Duke University Medical Center, Duke Cancer Center — Durham
  • Duke University Medical Center — Durham

District of Columbia

  • Sibley Memorial Hospital — Washington D.C.

New Mexico

  • University of New Mexico Comprehensive Cancer Center — Albuquerque

Ohio

  • Cleveland Clinic — Cleveland

Washington

  • Fred Hutchinson Cancer Center — Seattle

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-09-15
Est. Completion 2026-12-31
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04430738

The ClinicalTrials.gov registry entry for NCT04430738 describes a study currently listed as active not recruiting. 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 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Cholangiocarcinoma 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: NCT04430738 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Missouri, Colorado, Arizona. 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 NCT04430738 about?

NCT04430738 is a clinical study titled "Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers". This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating ca...

What is the current status of trial NCT04430738?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-09-15. Estimated completion is 2026-12-31.

What conditions does trial NCT04430738 study?

This clinical trial studies the following conditions: Cholangiocarcinoma, Colorectal Carcinoma, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gallbladder Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04430738?

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

Who is sponsoring clinical trial NCT04430738?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04430738 being conducted?

This trial has 20 study locations across Arizona, Colorado, District of Columbia, Missouri, New Mexico. 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