Spots Global Cancer Trial Database for Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
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Trial Identification
Brief Title: Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
Official Title: A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
Study ID: NCT04521686
Study Description
Brief Summary: This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.
Detailed Description: This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or IDH2 R140 or R172 mutant cholangiocarcinoma. This study includes 2 parts: Phase 1 dose escalation and Phase 1 dose expansion. The Phase 1 dose escalation monotherapy cohort will enroll any eligible patient with IDH1 R132-mutant advanced solid tumor or IDH1 or IDH2 mutant cholangiocarcinoma. The Phase 1 dose expansion will include 5 cohorts to further evaluate safety and clinical activity. Three cohorts will be administered LY3410738 monotherapy. The fourth cohort will administer LY3410738 at or below the monotherapy RP2D in combination with gemcitabine and cisplatin. The fifth cohort (US only) will administer LY3410738 at or below the monotherapy RP2D in combination with durvalumab. IDH1 R132, IDH2 R140, or IDH2 R172 mutations will be identified through genomic testing utilizing material collected prior to patient consent. Molecular assays utilized for enrollment are required to be performed in CLIA, ISO/IEC, CAP, or other similarly certified laboratory. Enrollment of patients with cholangiocarcinoma, chondrosarcoma or glioma may be made based on molecular tests performed in either tumor or blood. Enrollment of patients with other tumor types is limited to testing performed in tumor tissue.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic of Scottsdale, Phoenix, Arizona, United States
The University of Arizona Cancer Center, Tucson, Arizona, United States
USC Norris Cancer Hospital, Los Angeles, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
University of Chicago Pritzker School of Medicine, Chicago, Illinois, United States
Indiana University School of Medicine, Indianapolis, Indiana, United States
The John Hopkins Hospital, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, , France
Gustave Roussy, Villejuif Cedex, , France
Prince of Wales Hospital, Hong Kong, Shatin, New Territories, Hong Kong
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Osaka University Hospital, Suita-shi, Osaka, Japan
Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
China Medical University Hospital, Taichung City, , Taiwan
National Cheng-Kung Uni. Hosp., Tainan, , Taiwan
Contact Details
Name: Hui Liu
Affiliation: Medical Monitor
Role: STUDY_DIRECTOR
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