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)

Phase 1

Terminated

• Conditions: Acute Myelogenous Leukemia

• Registration Number: NCT00486265
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Study Start: 2007-07
• Study Completion: 2009-07
• Status Verified: 2010-07
• Results First Submitted: 2010-07-20
• Results First Submitted QC: 2010-07-20
• Results First Posted: 2010-08-17
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)	Response is evaluated after a maximum of 2 courses of induction therapy.	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 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.	To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)
To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]	PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.	Maximum plasma concentration, Cmax

Secondary Outcome Measures

Name	Time	Method
To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)	Response is evaluated after a maximum of 2 courses of induction therapy.	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	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.

Trial Locations

Locations (1)

Research Site; 🇨🇦 Toronto, Ontario, Canada