NCT00502385

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

First QC Date

July 13, 2007

Last Update Submit

January 20, 2011

Conditions

LeukaemiaMyelocyticAcute

Keywords

Phase IAMLde novo or secondary AMLAZD2171

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Efficacy, PK

Interventions

AZD2171DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Nick Botwood, BSc, MBBS, MRCP, MFPM

    AstraZeneca

    STUDY DIRECTOR

  • Dieter Hoelzer, MD, PhD

    Frankfurt University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Study Start

April 1, 2004

Last Updated

January 21, 2011

Record last verified: 2011-01