EUCTR2004-004685-32-GR进行中（未招募）1 期
A Pivotal Randomized Study of Lonafarnib (SCH66336) Versus Placebo in the Treatment of Subjects With Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) Who Are Platelet Transfusion Dependent With or Without Anemia - A pivotal study in CMML/MDS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects with de novo documented MDS or CMML according to FAB criteria
- •Subjects who are platelet transfusion dependent over an 8-week retrospective and 4-week prospective screening period (with at least 1 and no more than 8 platelet transfusions per 4-week period). Platelet transfusion data collected in the 4-week prospective period must confirm the data collected during the retrospective period.
- •Age of 18 years or older; ECOG performance status of 0 - 2.
- •Greater than 12 weeks (from randomization on Day -1) from any investigational drug, any chemotherapy, radiotherapy, immunotherapy, and from any treatment for MDS/CMML other than best supportive care.
- •Greater than 24 weeks (from randomization on Day -1) following bone marrow or peripheral stem cell transplantation or treatment with donor lymphocyte infusion.
- •Greater than 12 weeks (from randomization on Day-1) from any treatment with Oprelvekin, and treatment with erythropoetin or darbopoetin, unless given in stable doses over the 12 week screening period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •No secondary MDS
- •No grade >= 2 nausea or >= 1 vomiting (despite adequate antiemetic treatment) or any other condition that could interfere with taking oral medication.
- •No serum creatinine > 1.5 x upper limit of normal (ULN).
- •No bilirubin > 2mg/dl with the exception of documented Gilbert's Syndrome.
- •No AST/SGOT or ALT/SGPT > 2.5 x ULN, or Alkaline phosphatase > 4 x ULN.
- •No current or prior treatment with farnesyl transferase inhibitors.
- •No current treatment for MDS/CMML other than best supportive care.
研究者
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终止
3 期
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