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 1TerminatedNCT00486265

AstraZeneca47 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myelogenous Leukemia

Interventions

AZD4877DRUG

intravenous infusion administered on days 1, 2 and 3

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Research Site

Chicago, Illinois, United States

Research Site

Houston, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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)

Time frame: Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.

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.

Time frame: Response is evaluated after a maximum of 2 courses of induction therapy.

To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]

Maximum plasma concentration, Cmax

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.

Secondary Outcomes

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.

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.

Data from ClinicalTrials.gov

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