Phase 2
Completed N=12
AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Source: ClinicalTrials.gov NCT00071006 ↗Enrolled (actual)
12
Serious AEs
75.0%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 0 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
— | — |
| SECONDARY Percentage of Participants With Hematologic Improvement (HI) |
— | — |
| SECONDARY Duration of Response (DR) |
— | — |
| SECONDARY Bone Marrow Micro Vessel Density (MVD) |
— | — |
| SECONDARY Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation |
— | — |
| SECONDARY Plasma Vascular Endothelial Growth Factor (VEGF) Concentration |
— | — |
| SECONDARY Population Pharmacokinetics of Axitinib (AG-013736) |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00071006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.