Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)

This study has been terminated.
(AML assess. of response in Part B patients find treatment failure in all 8 evaluable for marrow response following a maximum of 2 induction courses of therapy)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00486265
First received: June 13, 2007
Last updated: December 7, 2010
Last verified: July 2010
  Purpose

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).

For enrollment information see the Central Contact information below


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: AZD4877
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs) [ Time Frame: Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period. ] [ Designated as safety issue: Yes ]
    To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)

  • To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR) [ Time Frame: Response is evaluated after a maximum of 2 courses of induction therapy. ] [ Designated as safety issue: No ]
    Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.

  • To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ] [ Time Frame: PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8. ] [ Designated as safety issue: No ]
    Maximum plasma concentration, Cmax


Secondary Outcome Measures:
  • To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR) [ Time Frame: Response is evaluated after a maximum of 2 courses of induction therapy. ] [ Designated as safety issue: No ]
    Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.

  • To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs [ Time Frame: Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible. ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: July 2007
Study Completion Date: July 2009
Intervention Details:
    Drug: AZD4877
    intravenous infusion administered on days 1, 2 and 3
  Eligibility

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

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
  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: NCT00486265

Locations
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Gregory A Curt, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00486265     History of Changes
Other Study ID Numbers: D2782C00007
Study First Received: June 13, 2007
Results First Received: July 20, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
Phase II
acute myelogenous leukemia
AML
cancer

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

ClinicalTrials.gov processed this record on August 28, 2014