Skip to main content
OpenTrials
Completed

NCT Number: NCT00926731

Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Le Chesnay, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed patient.
  • Provision of written informed consent.
  • De Novo (primary) or Secondary AML.
  • Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons.

Exclusion criteria

  • Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL).
  • Patients with blast crisis of chronic myeloid leukaemia.
  • Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).

Treatment and study plan

AZD1152

Drug

Variable dose via a 7-day continuous infusion

LDAC (low dose cytosine arabinoside)

Drug

20 mg subcutaneous injection given twice daily

Primary outcomes

  1. Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis

    Time frame: Information on these will be collected from the time of informed consent is signed, throughout the study.

Secondary outcomes

  1. Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.

    Time frame: During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 24, 2009
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.