Status:
TERMINATED
Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients
Lead Sponsor:
AstraZeneca
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
A Phase Ia/Ib, Open-Label, Multicentre, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 Administered Daily in Adult Patients with Recurrent or Refractory Ac...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01489722
Start Date
February 1 2012
End Date
May 1 2014
Last Update
August 11 2015
Active Locations (4)
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1
Research Site
Boston, Massachusetts, United States
2
Research Site
St Louis, Missouri, United States
3
Research Site
Houston, Texas, United States
4
Research Site
Toronto, Ontario, Canada