AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome

Treatments: Drug: AG-013736 (Axitinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00071006

A4061013

Details and patient eligibility

About

The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Poor prognosis AML or MDS
• Histological confirmation of diagnosis
• White blood cell count less than or equal to 30,000/mm3
• Adequate hepatic and renal function documented within 14 days prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• No evidence of preexisting uncontrolled hypertension
• Not a suitable candidate for chemotherapy
• No prior systemic chemotherapy treatment for AML or MDS or treatment with an anti-angiogenesis agent

Exclusion criteria

• Patients must not have exclusion criteria.
• Candidate for chemotherapy
• Patients with AML M3 (acute promyelocytic leukemia)
• Conditions that might confound the evaluation of safety or efficacy or increase patient risk.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single arm study

Experimental group

Treatment:

Drug: AG-013736 (Axitinib)