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

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Houston, Texas, 77030 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00071006
Pfizer
Completed
AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

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Descriptive Information
Brief Title  ICMJE AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Official Title  ICMJE Phase 2 Study Of AG-013736 In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome
Intervention  ICMJE Drug: AG-013736 (Axitinib)
patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.
Study Arms  ICMJE Experimental: Single arm study
Intervention: Drug: AG-013736 (Axitinib)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2012)
12
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
25
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion DateJuly 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00071006
Other Study ID Numbers  ICMJE A4061013
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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