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Brief Title: Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Official Title: A Phase 1b/2 Dose Escalation and Expansion Study of Tucatinib in Combination With Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Study ID: NCT04430738
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
Stanford Cancer Center / Blood and Marrow Transplant Program, Palo Alto, California, United States
University of Colorado Hospital / University of Colorado, Aurora, Colorado, United States
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado, Lafayette, Colorado, United States
Johns Hopkins Medical Center, Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University in St Louis, Saint Louis, Missouri, United States
New Mexico Cancer Center, Albuquerque, New Mexico, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Gabrail Cancer Center Research, LLC, Canton, Ohio, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
National Cancer Center Hospital, Chuo-ku, Other, Japan
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
St. Marianna University School of Medicine, Kawasaki-shi, Other, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Other, Japan
Aichi Cancer Center, Nagoya-shi, Other, Japan
Kindai University Hospital, Osakasayama-Shi, Other, Japan
Osaka International Cancer Institute, Osaka, Other, Japan
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR