ACTRN12612000970842撤回1 期
An exploratory Phase I/II safety and tolerability clinical evaluation of VAL-1000 in adults with Acute Leukaemias
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Male and Female subjects 18 years of age and over with AML, ALL or high-risk MDS (IPSS greater than Int-2), who are unsuitable for treatment with standard chemotherapy regimens, e.g., elderly (greater than 70 yrs.), poor risk (e.g. adverse risk karyotype) or who have failed up to 3 lines of therapy.
- •- Ability to communicate with trial staff, understand the Trial Information Sheet and sign the written informed consent, willing to follow the protocol requirements and comply with protocol restrictions and procedures.
- •- Secondary AML (including therapy-related) are included
- •- Life expectancy of greater than 3 months in relation to diseases other than AML/MDS
- •- ECOG performance status 0 – 3
- •- Adequate hepatic function as defined by bilirubin less than 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT)less than 2.5 x ULN
- •- Adequate renal function, with serum creatinine less than 1.5 x ULN
- •- Patients with no uncontrolled active infection
- •- Patient currently taking any investigational product or have received an investigational product within 28 days prior to screening.
- •- Hydroxyurea ceased 48 hours prior to study therapy
排除标准
- •- Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient’s ability to give informed consent or participate in the procedures or evaluations of the study
- •- Severe peripheral blood thrombocytopenia (<10 x 10^9/L) resistant to correction by platelet transfusion when measured 24 hours later
- •- Severe peripheral blood hyperleukocytosis (>50 X 10^9/L blast cells)
- •- Abnormal coagulation not corrected by plasma infusion (APTT > ULN or INR> 1.2)
- •- History of cerebrovascular disease (stroke within the past 2 years, any history of intracranial haemorrhage)
- •- History of major non-compliance to medication
- •- Evidence of CNS leukemia
- •- Uncontrolled infection
- •- Uncontrolled viral infection with known HIV or Hepatitis type B or C
- •- Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
- •- Any other concurrent severe and/or uncontrolled medical conditions (e.g. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol
- •- Patients of childbearing potential that do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
- •- Female patient who are pregnant or lactating.
- •- Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests two time the upper limit of normal range values)
研究者
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