Phase 2 N=12 Treatment

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

Acute Myeloid Leukemia (AML) · Myelodysplastic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00071006 ↗

Enrolled (actual)

Serious AEs

75.0%

Results posted

Mar 2012

Primary outcome: Primary: Percentage of Participants With Objective Response (OR) — 0 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AG-013736 (Axitinib) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jul 2004

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)	—	—

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.

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.

View full record on ClinicalTrials.gov →

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.