NCT Number: NCT00502385
Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML
The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Important dates
- Study start
- 2004
- First posted
- Jul 17, 2007
- Registry last updated
- Jan 21, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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