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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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)


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).


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 of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part A: Number of patients with dose limiting toxicities (DLTs) [Maximum Tolerated Dose (MTD) is defined as the maximum dose level below the dose level at which ≥ 33 % of at least 6 patients of a cohort experience DLTs during cycle 1.]

Outcome Time Frame:

28 days (cycle 1)

Safety Issue:

Yes

Principal Investigator

Becker Hewes, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sponsor GmbH

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

D4510C00001

NCT ID:

NCT01489722

Start Date:

February 2012

Completion Date:

January 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • AML
  • AZD1208
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Research SiteBeverly, Massachusetts  
Research SiteAbilene, Texas