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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00104065

Enrollment

Unknown

Registered

2005-02-23

Start date

2005-01-31

Completion date

2005-12-31

Last updated

2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatitis

Keywords

oral mucositis, oncology - supportive care, mouth diseases

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.

Interventions

DRUGCG53135-05, velafermin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026