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A Phase I/II, Open-Label, Multi-Center, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD4877 Administered on Days 1, 2 and 3 in Adult Patients With Recurrent or Refractory Acute Myelogenous Leukemia (AML) Excluding Promyelocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia

Thank you

Trial Information

A Phase I/II, Open-Label, Multi-Center, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD4877 Administered on Days 1, 2 and 3 in Adult Patients With Recurrent or Refractory Acute Myelogenous Leukemia (AML) Excluding Promyelocytic Leukemia


Inclusion Criteria:



- Part A: Relapsed or refractory leukemia for which no standard therapies are
anticipated to result in a durable remission

- Part B: AML who have had no more than two prior relapses or failed to achieve
remission after at least one induction treatment.

- Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks
or more off immunosuppressive therapy

Exclusion Criteria:

- Promyelocytic acute myelogenous leukemia

- Prior allogeneic transplant requiring immunosuppressive therapy or treating physician
does not consider patient to be a candidate for allogeneic transplantation.

- Liver injury

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:

To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)

Outcome Description:

To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.

Safety Issue:

Yes

Principal Investigator

Gregory A Curt, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D2782C00007

NCT ID:

NCT00486265

Start Date:

July 2007

Completion Date:

July 2009

Related Keywords:

  • Acute Myelogenous Leukemia
  • Phase I
  • Phase II
  • acute myelogenous leukemia
  • AML
  • cancer
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
Research Site Arlington Heights, Illinois  
Research Site Abilene, Texas