Study on Tucatinib with Trastuzumab and Chemotherapy or Pembrolizumab for HER2+ Gastrointestinal Cancers
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
ClinicalTrials ID:NCT04430738
This clinical trial is testing a combination of drugs, including tucatinib, trastuzumab, and chemotherapy or pembrolizumab, to see if they are safe and effective for treating HER2-positive gastrointestinal cancers.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if the drug tucatinib is safe when used with trastuzumab and other cancer treatments like pembrolizumab, FOLFOX, and CAPOX. Researchers will monitor any side effects and evaluate how well this combination works in treating HER2-positive cancers in the stomach, intestines, or gallbladder.
Eligibility Criteria
Inclusion Criteria
- Have a type of cancer that cannot be removed by surgery or has spread, specifically:
- Colorectal cancer (CRC)
- Stomach cancer
- Gastroesophageal junction (GEJ) cancer
- Esophageal cancer
- Bile duct cancer
- Gallbladder cancer
- Be eligible to receive a treatment plan that includes oxaliplatin, except for certain groups.
- Have HER2-positive cancer, confirmed by previous or local lab tests.
- For Phase 1b: Have cancer that can be measured or not measured by scans.
- For Phase 2: Have cancer that can be measured by scans.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have a known allergy to the study drugs.
- Test positive for Hepatitis B or C.
- For certain groups: Have had previous anti-HER2 treatments.
- For other groups: Have had previous treatments with specific immune therapies and stopped due to severe side effects.
Additional criteria may apply, and the study center will determine eligibility.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital | 85054 | Phoenix | Arizona |
| Mayo Clinic | 85259 | Scottsdale | Arizona |
| University of Colorado Denver CTO(CTRC) | 80045 | Aurora | Colorado |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | 80045 | Aurora | Colorado |
| University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) | 80045 | Aurora | Colorado |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | 80045 | Aurora | Colorado |
| PCM Trials | 80218 | Denver | Colorado |
| Sibley Memorial Hospital | 20016 | Washington D.C. | District of Columbia |
| Siteman Cancer Center - St Peters | 63376 | City of Saint Peters | Missouri |
| Siteman Cancer Center - West County | 63141 | Creve Coeur | Missouri |
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