Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients
Stopped early · Phase 1
Conditions studied: Acute Myeloid Leukemia
In brief
The purpose of this open label study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AZD1208 in patients with recurrent or refractory Acute Myelogenous Leukemia (AML). This study will have two parts. In Part A, patients will receive escalating doses to identify the maximum tolerated dose (MTD). In Part B, the efficacy of the maximum tolerated dose will be evaluated in a expanded group of patients.
Key facts
- Study ID
- NCT01489722
- Run by
- AstraZeneca
- People needed
- 55
- Starts
- 2012-02-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2015-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females at least 18 years of age
- Patients with relapsed or refractory Acute myelogenous leukemia (AML) or AML secondary to myelodysplastic syndromes, myeloproliferative neoplasm, or chronic myelogenous leukemia
- Eastern Oncology Cooperative Group (ECOG) performance status 0-2 and considered likely to complete at least 4 weeks of therapy
You may not qualify if…
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV.
- Active heart disease including myocardial infarction within the last 3 months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication or uncontrolled congestive heart failure
- Prior allogeneic transplant requiring immunosuppressive therapy (Patients with prior allogeneic transplants who remain clinically stable for ≥ 2 weeks or more off immunosuppressive therapy, are eligible)
- White blood cell count ≥ 100,000/mm3 (100x10*9/L)
- Type 1 Diabetes or uncontrolled Type II Diabetes
- HbA1C ≥8% or fasting blood glucose >160 mg/Dl (>8.9 mmol/L)
- Baseline fasting total cholesterol >300 mg/dL (>7.75 mmol/L)
Where it is running
- Research Site — Boston, Massachusetts, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Houston, Texas, United States
- Research Site — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.