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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)


Phase 1
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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)


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Paul Stockman

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1531C00018

NCT ID:

NCT00926731

Start Date:

June 2009

Completion Date:

May 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukaemia (AML)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Research SiteAkron, Ohio  
Research SiteAbilene, Texas