NCT00284804已完成2 期
An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
Bristol-Myers Squibb17 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 17
- 主要终点
- Overall response rate
研究概览
简要总结
This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
详细描述
Secondary objectives include:
- to characterize progression-free survival
- to characterize time to progression
- to determine response duration
- to characterize the effect of study drug on health-related quality of life
- to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population
- to characterize the immunogenicity response of MDX-060
- to characterize the safety of MDX-060, and
- to characterize the pharmacokinetic profile of MDX-060
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of Hodgkin's disease [HD] (excluding HIV-associated HD)
- •Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
- •Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
- •ECOG Performance Status of 0-2
- •Patients must have bi-measurable disease
- •At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
- •Life expectancy 12 weeks or greater
- •Screening laboratory values must be met
- •Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.
排除标准
- •Previous treatment with any anti-CD30 antibody
- •History of allogeneic transplant
- •Any tumor lesion 10cm or greater in diameter
- •Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
- •Any significant active or chronic infection
- •Apparent active or latent tuberculosis (TB) infection
- •Patients who are pregnant or nursing
- •Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
- •Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
研究组 & 干预措施
MDX-060 plus standard of care
Experimental
MDX-060 in combination with gemcitabine
干预措施: MDX-060 (Drug)
Standard of care
Active Comparator
Gemcitabine
干预措施: MDX-060 (Drug)
结局指标
主要结局
Overall response rate
时间窗: Day 50/57
次要结局
- Progression-free survival(Day 50/57)
研究者
研究点 (17)
Loading locations...
相似试验
终止
2 期
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)Lymphoma, Mantle-CellNCT02455297Bayer4
进行中（未招募）
2 期
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial CancerUrothelial CancerNCT02365597Janssen Research & Development, LLC239
已完成
2 期
KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)Adult T-cell Leukemia-LymphomaNCT01626664Kyowa Kirin, Inc.71
进行中（未招募）
2 期
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.Esophageal Squamous Cell CarcinomasNCT05022654Sichuan Baili Pharmaceutical Co., Ltd.22
终止
2 期
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)Recurrent Glioblastoma Multiforme (GBM)NCT00290771Novartis231