Spots Global Cancer Trial Database for Phase 2 Study of DKN-01 in Colorectal Cancer
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Trial Identification
Brief Title: Phase 2 Study of DKN-01 in Colorectal Cancer
Official Title: Randomized Phase 2 Study of DKN-01 Plus FOLFIRI/FOLFOX and Bevacizumab Versus FOLFIRI/FOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer (DeFianCe)
Study ID: NCT05480306
Study Description
Brief Summary: This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) \[FOLFIRI/FOLFOX and bevacizumab\] as second-line treatment of advanced CRC patients.
Detailed Description: This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) \[FOLFIRI/FOLFOX and bevacizumab\] as second-line treatment of advanced CRC patients. In Parts A and B, approximately 150 evaluable adult advanced CRC patients with measurable disease (RECIST v1.1) who have radiographically progressed during or following 1 line of systemic treatment will be enrolled in the study. The study consists of a Screening Period, a Treatment Period, a Safety Follow-up Period (SFUP) and a Long-Term Follow-up Period (LTFU). Patients will be followed in the SFUP for approximately 30 days (+7 days) after the last administration of study drug and then enter the LTFU period to be followed for survival and subsequent therapies. Additionally, patients that ended study treatment for a reason unrelated to progressive disease \[PD\] will also be followed for disease progression in the LTFU period.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
UCLA, Los Angeles, California, United States
Florida Cancer Specialists & Research Institute (FCS), Cape Coral, Florida, United States
Florida Cancer Specialists & Research Institute, Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute, Gainesville, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Florida Cancer Specialists & Research Institute, Wellington, Florida, United States
Hematology Oncology of Indiana, PC - Indianapolis, Indianapolis, Indiana, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Oncology Hematology Associates - Springfield, Springfield, Missouri, United States
Northwell Health, Lake Success, New York, United States
New York University, New York, New York, United States
Cornell University, New York, New York, United States
Mount Sinai Medical Center - New York, New York, New York, United States
White Plains Hospital, White Plains, New York, United States
Messino Cancer Centers, Asheville, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University, Winston-Salem, North Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Sanford Cancer Center, Sioux Falls, South Dakota, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
MultiCare Tacoma General Hospital, Tacoma, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Universitaetsklinikum Hamburg-Eppendorf (UKE) - Universitaeres Cancer Center Hamburg (UCCH), Hamburg, , Germany
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT), Heidelberg, , Germany
SLK-Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen - Klinik fuer Innere Medizin III, Heilbronn, , Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie - Magdeburg, Magdeburg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Dong-A University Medical Center, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
CHA University - Bundang CHA General Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea - St. Vincent's Hospital, Suwon, , Korea, Republic of
Contact Details
Name: Cynthia Sirard, MD
Affiliation: Leap Therapeutics, Inc.
Role: STUDY_DIRECTOR
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