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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00502385
• Collaborator: (none)
• Enrollment: 54

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukaemia; Myelocytic; Acute	Drug: AZD2171	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Efficacy, PK []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
• Principal Investigator: Dieter Hoelzer, MD, PhD, Frankfurt University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00502385
• Other Study ID Numbers: D8480C00002
• First Posted: Jul 17, 2007
• Last Update Posted: Jan 21, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Phase I; AML; de novo or secondary AML; AZD2171
• Additional relevant MeSH terms: Cediranib

Study Results

No Results Posted as of Jan 21, 2011