CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
AG-013736 (Axitinib)drug
Likely dose
Axitinib 5 mg orally twice daily (continuous dosing)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed poor prognosis AML or MDS
  • ✓ECOG performance status 0, 1, or 2
  • ✓WBC ≤30,000/mm³
  • ✓Adequate hepatic and renal function within 14 days prior to registration
Key exclusion· 5
  • ✕Suitable candidate for chemotherapy
  • ✕AML M3 (acute promyelocytic leukemia)
  • ✕Prior systemic chemotherapy for AML or MDS
  • ✕Prior anti-angiogenesis agent treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00071006
NCT00071006Phase 2Completed
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Phase 2 Study Of AG-013736 In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

Pfizer·interventional·Posted Oct 13, 2003·Updated Jun 8, 2012

In Brief

A Phase 2 clinical trial evaluating AG-013736 (Axitinib) for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML), Myelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2003
Enrollment StartSep 1, 2003
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 22.7 years ago

Interventions

AG-013736 (Axitinib)drug

patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.