The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a particular gene (known as the RET gene). Participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Oral
UCLA Medical Center
Los Angeles, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
DLT rate
Time frame: During the first 28-day cycle of LOXO-260 treatment
Phase 1b: To assess the antitumor activity: Overall response rate (ORR)
ORR per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Time frame: Up to approximately 24 months or 2 years
To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260
PK: Mean concentration of LOXO-260
Time frame: Up to approximately 24 months or 2 years
To assess the antitumor activity of LOXO-260: ORR
ORR per RECIST 1.1
Time frame: Up to approximately 24 months or 2 years
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Emory University
Atlanta, Georgia, United States
University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 6 more locations