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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Leukaemia; Acute; Myelocytic

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502385

D8480C00002

Details and patient eligibility

About

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

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)