Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CG53135-05, velafermin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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