Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML

AstraZeneca54 enrolled

Overview

The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukaemia Myelocytic Acute

Interventions

AZD2171DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of written informed consent * Male/female, 18 yrs or over * WHO performance status 0-2 * Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy Exclusion Criteria: * Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3 * Previous treatment against new blood vessel formation (anti-angiogenic) * Chest X-ray showing leukaemia in the lungs

Outcomes

Primary Outcomes

The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry

Secondary Outcomes

Efficacy, PK

Data from ClinicalTrials.gov

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