Sponsor study identifier
interventional
12
1 country
1
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2004
Actual (reported)Study Completion
July 2004
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2004
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
October 9, 2003
Actual (reported)October 13, 2003
Actual (reported)July 2004
Actual (reported)July 2004
Actual (reported)March 19, 2012
Actual (reported)Percentage of Participants With Objective Response (OR)
Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with \> 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, \<5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively.
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks
Percentage of Participants With Hematologic Improvement (HI)
Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)
Duration of Response (DR)
First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks
Bone Marrow Micro Vessel Density (MVD)
Day 1, Week 2 thereafter every 4 weeks up to 35 weeks
Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation
Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)
Plasma Vascular Endothelial Growth Factor (VEGF) Concentration
Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)
patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer CT.gov Call Center
Pfizer
12 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2003
First Posted
October 13, 2003
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2004
Actual (reported)Study Completion
July 2004
Actual (reported)Last Updated
June 8, 2012
Results First Posted
March 19, 2012
Record last verified: 2012-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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