Spots Global Cancer Trial Database for Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
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Trial Identification
Brief Title: Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
Official Title: A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors
Study ID: NCT04956640
Study Description
Brief Summary: The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.
Detailed Description: This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors. This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.
Keywords
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
USC Norris Cancer Hospital, Los Angeles, California, United States
Chao Family Comprehensive Cancer Ctr., Orange, California, United States
Yale-New Haven Hospital, New Haven, Connecticut, United States
AdventHealth Orlando, Orlando, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Indiana Univ Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States
Community Health Network, Indianapolis, Indiana, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
NYU Langone Health- Long Island, Mineola, New York, United States
NYU Langone, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Novant Health Cancer Institute - Elizabeth, Charlotte, North Carolina, United States
Novant Health Cancer Institute - Forsyth, Winston-Salem, North Carolina, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Vanderbilt Univeristy School of Medicine, Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
START Mountain Region, West Valley City, Utah, United States
Inova Health System IRB, Fairfax, Virginia, United States
USO-Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
University of Wisconsin-Madison Hospital and Health Clinic, Madison, Wisconsin, United States
Royal North Shore Hospital, St Leonards, New South Wales, Australia
St Vincent's Hospital Sydney, Sydney, New South Wales, Australia
Cancer Research SA, Adelaide, South Australia, Australia
Peninsula and Southeast Oncology, Frankston, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Hospital (Ontario), Toronto, Ontario, Canada
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, Aquitaine, France
Centre Leon Berard, Lyon, Rhône-Alpes, France
Institut du Cancer de Montpellier - Val d'aurelle, Montpellier Cedex 5, , France
Institut Curie, Paris CEDEX 05, , France
Institut Claudius Regaud - IUCT Oncopole, Toulouse cedex, , France
Gustave Roussy, Villejuif Cedex, , France
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital, Wakayama, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, Jeonranamdo, Korea, Republic of
Seoul National University Hospital, Seoul, Korea, Korea, Republic of
Asan Medical Center, Seoul, Korea, Korea, Republic of
Contact Details
Name: Melinda Willard, PhD
Affiliation: Loxo Oncology, Inc.
Role: STUDY_DIRECTOR
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