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A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.


Phase 1
18 Years
N/A
Not Enrolling
Both
Myeloid Leukemia

Thank you

Trial Information

A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.


Inclusion Criteria:



- Relapsed or refractory AML for which no standard therapies are anticipated to result
in durable remission

- Newly diagnosed AML who are not considered suitable for other treatments.

Exclusion Criteria:

- Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation,
radiotherapy or chemotherapy within 4 weeks of first dose.

- Participation in any other trial with an investigational product within the previous
30 days

- Other active malignancy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.

Outcome Time Frame:

Assessed at each visit

Principal Investigator

Paul Stockman, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1531C00007

NCT ID:

NCT00497991

Start Date:

May 2006

Completion Date:

April 2010

Related Keywords:

  • Myeloid Leukemia
  • AML
  • phase I/II
  • AZD1152
  • Acute Myeloid Leukaemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
Research Site Albany, New York  
Research Site Abilene, Texas