NCT00323518已完成2 期
A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 32
- 主要终点
- the incidence of grade 3/4 oral mucositis using WHO grading system
研究概览
简要总结
CG53135-05 (velafermin), 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 confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-
- •Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.
- •ECOG Performance Score of 2 or less
- •Signed Informed Consent Form (ICF)
排除标准
- •Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
- •Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C
- •Patients with known hypersensitivity to recombinant protein therapeutics
- •Patients who have taken velafermin (CG53135-05) previously
- •Patients who have taken palifermin in the past 90 days
- •Patients who have taken 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 OM at the time of randomization
- •Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent
- •Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments
- •Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.
研究组 & 干预措施
1
Placebo Comparator
placebo
干预措施: placebo (Drug)
2
Experimental
30 mcg/kg velafermin
干预措施: velafermin (Drug)
3
Experimental
10 mcg/kg velafermin
干预措施: velafermin (Drug)
4
Experimental
60 mcg/kg velafermin
干预措施: velafermin (Drug)
结局指标
主要结局
the incidence of grade 3/4 oral mucositis using WHO grading system
时间窗: evaluated throughout the study
次要结局
未报告次要终点
研究者
研究点 (32)
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