EUCTR2013-002447-29-ES进行中（未招募）1 期
A phase I study of Human Pharmacokinetics and Safety of ORY-1001, and LSD1 inhibitor, in relapsed or refractory acute leukaemia (AL)
Oryzon Genomics S.A.0 个研究点目标入组 30 人开始时间: 2013年9月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Patients aged 16 and above.
- •2. Patients must have relapsed or refractory AL (exluding promyelocytic leukaemia) considered by the investigator ineligible for intensive chemotherapy regimen at that time
- •3. Patients must have ECOG Performance Status (PS) of 0-2
- •4. Women of child-bearing potential must have negative serum or urine pregnancy test within two weeks prior treatment start
- •5. Fertile male or female patients must use highly efficient contraception for the duration of the study and 6 months after the last ORY-1001 dose.
- •6. Male patients must use condoms to avoid drug exposure of their partner.
- •7. Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent
- •8. Life expectancy of at least 2 months
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Cancer history that according to the investigator might confound the assessment of the study endpoints
- •2. Patients with uncontrolled hypertension or diabetes, hepatitis or HIV.
- •3. Inter-current illness or social situation that will limit compliance with study requirements
- •4. Pregnancy or lactating / breast feeding
- •5. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities if entered into the clinical study
- •6. Acute myeloid leukaemia treatment within the previous 14 days. Hydroxyurea or 6-mercaptopurine are allowed until 12 hours prior study treatment start and after the first treatment block (day 1-5) in case of hyperleucocytosis.
- •7. Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: Tranylcypromine or Phenelzine.
- •8. Radiotherapy less than 2 weeks prior to the start of the study
研究者
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