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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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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