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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
History of Changes

June 13, 2007
December 7, 2010
July 2007
Not Provided
  • 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
To identify a MTD of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs), assess the effect of AZD4877 on the rate of complete remission (CR) and determine the PK profile of AZD4877 on a daily x 3 schedule.
Complete list of historical versions of study NCT00486265 on ClinicalTrials.gov Archive Site
  • 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 ]
To assess the effect of AZD4877 on rate and duration of CR, CRp, PR and overall response (CR,CRp, or PR) and evaluate the safety and tolerability of AZD4877 on a daily x 3 schedule by assessment of Adverse Events, non-hematologic labs and vital signs.
Not Provided
Not Provided
 
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)
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

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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia
Drug: AZD4877
intravenous infusion administered on days 1, 2 and 3
Not Provided
Kantarjian HM, Padmanabhan S, Stock W, Tallman MS, Curt GA, Li J, Osmukhina A, Wu K, Huszar D, Borthukar G, Faderl S, Garcia-Manero G, Kadia T, Sankhala K, Odenike O, Altman JK, Minden M. Phase I/II multicenter study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD4877 in patients with refractory acute myeloid leukemia. Invest New Drugs. 2012 Jun;30(3):1107-15. Epub 2011 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
July 2009
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00486265
D2782C00007
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Gregory A Curt, MD AstraZeneca
AstraZeneca
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP