Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
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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.
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 Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients ages > 18 yrs
Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation.
Patients with Karnofsky performance scores > or = 70%
Informed consent for participation in study
Patients who weigh < 33 kg
Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation
Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C
Patients with known hypersensitivity to recombinant protein therapeutics
Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days
Patients who have untreated symptomatic dental infection
Patients with a history of sensitivity or allergy to E. coli-derived products
Patients with WHO Grade 3 or 4 oral mucositis (OM)