NCT00926731已完成1 期
A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis
研究概览
简要总结
A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patient.
- •Provision of written informed consent.
- •De Novo (primary) or Secondary AML.
- •Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons.
排除标准
- •Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL).
- •Patients with blast crisis of chronic myeloid leukaemia.
- •Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).
研究组 & 干预措施
1
Experimental
AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)
干预措施: AZD1152 (Drug)
1
Experimental
AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)
干预措施: LDAC (low dose cytosine arabinoside) (Drug)
结局指标
主要结局
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis
时间窗: Information on these will be collected from the time of informed consent is signed, throughout the study.
次要结局
- Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.(During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) PatientsAcute Myeloid LeukemiaNCT00952588AstraZeneca74
已完成
1 期
Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19COVID-19NCT04684446R-Pharm100
已完成
1 期
Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese SubjectsHealthyNCT01335451AstraZeneca48
招募中
2 期
Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML ProfilingAcute Myeloid LeukemiaNCT05431257Rigshospitalet, Denmark117
已完成
1 期
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer PatientsFGFR Inhibition, Pharmacokinetics, BiomarkersER+ Breast CancerNCT01202591AstraZeneca127