Spots Global Cancer Trial Database for Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
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Trial Identification
Brief Title: Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of CG53135-05 Administered Intravenously as a Single Dose for the Prevention of Oral Mucositis in Patients Receiving Autologous Hematopoietic Stem Cell Transplant
Study ID: NCT00104065
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Facility, LaJolla, California, United States
Research Facility, Denver, Colorado, United States
Research Facility, Miami, Florida, United States
Research Facility, Chicago, Illinois, United States
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
Contact Details
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