Spots Global Cancer Trial Database for Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
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Trial Identification
Brief Title: Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
Official Title: MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer
Study ID: NCT03043313
Conditions
Study Description
Brief Summary: This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Pacific Shores Medical Group, Long Beach, California, United States
Keck Medical Center / University of Southern California, Los Angeles, California, United States
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Stanford University School of Medicine, Palo Alto, California, United States
Saint Joseph Heritage Medical Group, Santa Rosa, California, United States
Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, United States
Lombardi Cancer Center / Georgetown University Medical Center, Washington, District of Columbia, United States
Florida Cancer Specialists - South Region, Fort Myers, Florida, United States
Florida Cancer Specialists - North Region, Saint Petersburg, Florida, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University / University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology - Beaumont, Beaumont, Texas, United States
Texas Oncology - Baylor Sammons Cancer Center, Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Texas Oncology - McAllen, McAllen, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Providence Regional Medical Center Everett, Everett, Washington, United States
Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Aurora Research Institute Cancer Center, Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint Luc, Brussels, Other, Belgium
Universitair Ziekenhuis Antwerpen, Edegem, Other, Belgium
UZ Leuven campus Gasthuisberg, Leuven, Other, Belgium
Hospitalier Jean Minjoz, Besancon, Other, France
Center Georges Francois Leclerc, Dijon, Other, France
Hôpital Franco-Britannique - Fondation Cognacq-Jay, Levallois-Perret, Other, France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes, Lyon, Other, France
Hopital Saint-Antoine, Paris, Other, France
Instituto Europeo di Oncologia, Milan, Other, Italy
Niguarda Ca' Granda Hospital, Milan, Other, Italy
Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara, Pisa, Other, Italy
Hospital Universitario Vall d'Hebron, Barcelona, Other, Spain
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), L'Hospitalet de Llobregat, Other, Spain
Hospital General Universitario Gregorio Maranon, Madrid, Other, Spain
Hospital Clinico Universitario de Valencia, Valencia, Other, Spain
Contact Details
Name: John H Strickler
Affiliation: Academic and Community Cancer Research United
Role: STUDY_CHAIR
Name: Jorge Ramos, DO
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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