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)

Acute Myelogenous Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00486265
• Other study ID #: D2782C00007
• Status: Terminated
• Phase: Phase 1
• First received: June 13, 2007
• Last updated: December 7, 2010
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• AZD4877
intravenous infusion administered on days 1, 2 and 3

Locations

Country	Name	City	State
Canada	Research Site	Toronto	Ontario
United States	Research Site	Chicago	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)	To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)	Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.	Yes
Primary	To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)	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.	Response is evaluated after a maximum of 2 courses of induction therapy.	No
Primary	To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]	Maximum plasma concentration, Cmax	PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.	No
Secondary	To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)	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.	Response is evaluated after a maximum of 2 courses of induction therapy.	No
Secondary	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		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.	Yes

External Links

•   US and Canada only