NCT01702155已完成1 期
A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of DFP-10917 given via continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).
详细描述
This study will determine the safety and efficacy of DFP-10917 in patients with AML or ALL. The Phase I dose-escalation portion of the study will determine the highest tolerable dose and regimen (7 or 14 day continuous infusion) based on safety data in patients with refractory or relapsed AML or ALL. The phase II portion will investigate the safety and efficacy of DFP-10917, at the dose and regimen to be determined in the Phase I portion, in patients with refractory or relapsed AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available Phase II Only: Patient must have histologically or pathologically confirmed diagnosis of AML based on WHO classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. Patients aged 60 years or older with newly diagnosed AML who are not eligible for, or who refuse, standard care are also eligible.
- •Aged ≥ 18 years.
- •ECOG Performance Status of 0, 1 or
- •Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution, bilirubin <=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 x ULN).
- •Absence of CNS involvement by leukemia.
- •Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
- •Signed informed consent prior to the start of any study specific procedures.
- •Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
排除标准
- •The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
- •Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
- •Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
- •Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
- •A pregnant or lactating woman.
- •Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
- •Patient has acute promyelocytic leukemia (APL).
- •Patients with known HIV, HBV or HCV infection (note: testing for these infections is not required).
- •Documented or known clinically significant bleeding disorder.
研究组 & 干预措施
DFP-10917
Experimental
- 7-day continuous infusion (in the vein): Starting dose 4 mg/m^2
- 14-day continuous infusion (in the vein): Starting dose 10 mg/m^2
- Phase II Only: 6 mg/m^2 for the 14-day continuous infusion (in the vein)
干预措施: DFP-10917 (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: Up to 30 days after the last dose
次要结局
未报告次要终点
研究者
研究点 (1)
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