NCT00071006

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

March 19, 2012

Completed
Last Updated

June 8, 2012

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

October 9, 2003

Results QC Date

February 25, 2012

Last Update Submit

May 31, 2012

Conditions

Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (1)

Single arm study

EXPERIMENTAL
Drug: AG-013736 (Axitinib)

Interventions

AG-013736 (Axitinib)DRUG

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

Single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Candidate for chemotherapy
  • Patients with AML M3 (acute promyelocytic leukemia)
  • Conditions that might confound the evaluation of safety or efficacy or increase patient risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2003

First Posted

October 13, 2003

Study Start

September 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

June 8, 2012

Results First Posted

March 19, 2012

Record last verified: 2012-05

Locations

US(1)