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NCT03929666 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
A Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 20
- Study locations
NCT03929666 is a Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 74 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT03929666, a Phase 2 study of HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG ZW25 (Zanidatamab)
Study Locations (20)
Other
- Centro de Investigacion Clinica SAGA - Santiago
- Icegclinic Research & Care - Santiago
- CECIM Biocinetic - Santiago
- Centro Internacional de Estudios Clínicos - Santiago
- Pusan National University - Busan
- Korea University Anam Hospital - Seoul
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
Ontario
- The Ottawa Hospital Cancer Centre - Ottawa
- Princess Margaret Cancer Center - Toronto
Florida
- H. Lee Moffitt Cancer Center - Tampa
Illinois
- University of Chicago - Chicago
Michigan
- The Cancer and Hematology Centers - Grand Rapids
Nebraska
- Nebraska Methodist Hospital - Omaha
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2025-08-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03929666
The ClinicalTrials.gov registry entry for NCT03929666 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT03929666 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Ontario.
Frequently Asked Questions
What is clinical trial NCT03929666 about?
NCT03929666 is a clinical study titled "A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer". This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those w...
What is the current status of trial NCT03929666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2019-08-29. Estimated completion is 2025-08-30.
What conditions does trial NCT03929666 study?
This clinical trial studies the following conditions: HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer.
What interventions are being tested in trial NCT03929666?
The interventions under investigation include: Capecitabine (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), ZW25 (Zanidatamab) (DRUG).
Who is sponsoring clinical trial NCT03929666?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03929666 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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