Acute Myeloid Leukemia Clinical Trial

Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients

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 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.

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Full 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 Acute Myelogenous Leukemia (AML).

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

55

Study ID:

NCT01489722

Recruitment Status:

Terminated

Sponsor:

AstraZeneca

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There is 1 Location for this study

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Research Site
Boston Massachusetts, , United States
Research Site
St. Louis Missouri, , United States
Research Site
Houston Texas, , United States
Research Site
Toronto Ontario, , Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

55

Study ID:

NCT01489722

Recruitment Status:

Terminated

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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