Phase I, Open-Label, Dose-Escalation, Safety and Pharmacokinetics (PK) Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00486265

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 I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: daily x 3 schedule ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 by assessment of Adverse Events, non-hematologic labs and vital signs. [ Time Frame: daily x 3 schedule ] [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2010

Intervention Details:

intravenous infusion administered three times a day

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486265

Contacts

Contact: AstraZeneca Cancer Study Locator Service	1-877-400-4656	astrazeneca@emergingmed.com
Contact: AstraZeneca Information, Outside US	1-866-992-9276

Locations

United States, Illinois
Research Site	Recruiting
Chicago, Illinois, United States
United States, Texas
Research Site	Recruiting
Houston, Texas, United States
Research Site	Recruiting
San Antonio, Texas, United States
Canada, Ontario
Research Site	Recruiting
Toronto, Ontario, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Gregory A Curt, MD

AstraZeneca

More Information

US and Canada only This link exits the ClinicalTrials.gov site

Study ID Numbers:	D2782C00007
Study First Received:	June 13, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00486265
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase I
Phase II
acute myelogenous leukemia
AML
cancer

Study placed in the following topic categories:

Leukemia
Acute promyelocytic leukemia
Acute myelogenous leukemia
Leukemia, Promyelocytic, Acute

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009