Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00497991
First received: July 5, 2007
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.


Condition Intervention Phase
Myeloid Leukemia
Drug: AZD1152
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: Assessed at each visit ]
  • To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis [ Time Frame: Change from baseline ]

Secondary Outcome Measures:
  • To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability [ Time Frame: Assessed at each visit ]

Enrollment: 65
Study Start Date: May 2006
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497991

Locations
United States, New York
Research Site
New York, New York, United States
United States, Texas
Research Site
Houston, Texas, United States
France
Research Site
Angers Cedex, France
Research Site
Grenoble Cedex, France
Research Site
Le Chesnay Cedex, France
Italy
Research Site
Bologna, Italy
Research Site
Roma, Italy
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Rotterdam, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paul Stockman, MD AstraZeneca
Principal Investigator: Bob Lowenberg, MD, PhD Cancer Institute
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00497991     History of Changes
Other Study ID Numbers: D1531C00007, EUDRACT number 2005-004243-65
Study First Received: July 5, 2007
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
AML
phase I/II
AZD1152
Acute Myeloid Leukaemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 29, 2014