Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)