NCT00045786已完成2 期
A Multi-center, An Open Label, Dose-Escalation Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment for Myelodysplastic Syndromes
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
- Celgene
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
- •Age ≥ 18 at the time of signing informed consent
- •Patient must be able to adhere to the study visit schedule and other protocol requirements.
- •Patient must understand and voluntarily sign an informed consent document.
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
- •Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- •Women must not be pregnant or lactating.
- •Exclusion Criteria
- •Pregnant and lactating women and WCBP who are not using adequate contraception.
- •Myelosclerosis (or myelofibrosis) occupying >30% of marrow space
- •Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL.
- •Patients with uncorrected Bl2 or folate deficiency.
- •Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss.
- •Patients with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- •Patients with clinically significant, symptomatic and unstable pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary system diseases unrelated to their underlying hematologic disorder.
- •Life-threatening or active infection requiring parenteral antibiotic therapy or other serious concurrent illness.
- •Patients who have a history of testing positive for Hepatitis B surface antigenemia,'Hepatitis C, or HIV.
- •Inadequate organ hction: renal insufficiency [serum creatinine levels >1.5 x upper limit of normal (ULN)] or hepatic impairment (bilirubin 22 mg/dL or AST/ALT 22 x ULN).
- •Patients may not have received another investigational study drug within 30 days of entry in the present study.
- •Requirement for ongoing therapy with corticosteroids.
排除标准
- 未提供
研究组 & 干预措施
400 mg CC-1088
Experimental
干预措施: CC-1088 (Drug)
800 mg CC-1088
Experimental
干预措施: CC-1088 (Drug)
1200 mg CC-1088
Experimental
干预措施: CC-1088 (Drug)
1500 mg CC-1088
Experimental
干预措施: CC-1088 (Drug)
研究者
研究点 (1)
Loading locations...
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