CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Research Facility
La Jolla, California, United States
Research Facility
Denver, Colorado, United States
Research Facility
Miami, Florida, United States
Research Facility
Chicago, Illinois, United States
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Research Facility
Worcester, Massachusetts, United States
Research Facility
New York, New York, United States
Research Facility
Winston-Salem, North Carolina, United States
Research Facility
Cleveland, Ohio, United States
Research Facility
Portland, Oregon, United States