This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
REC-4881 4mg capsules
Sharp Memorial Hospital
San Diego, California, United States
Sansum Clinic
Santa Barbara, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Number of Participants with Dose Limiting Toxicities
Time frame: Up to 24 months
Objective Response Rate
Time frame: Up to 24 months
Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
Time frame: pre-dose and up to 24 months
Disease Control Rate
Time frame: Up to 24 months
Duration of response
Time frame: Up to 24 months
Duration of Stable Disease
Time frame: Up to 24 months
Time to Response
Time frame: Up to 24 months
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Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Cancer Specialists of North Florida
Fleming Island, Florida, United States
Mission Cancer And Blood
Des Moines, Iowa, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Hunterdon Hematology Oncology
Hillsborough, New Jersey, United States
...and 3 more locations