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

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NCT00071006

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Study Location
Pfizer Investigational Site
Houston, Texas, 77030, United States
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Contact
1-800-718-1021
[email protected]
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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.

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Acute Myeloid Leukemia (AML), Myelodysplastic SyndromeAG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS) NCT00071006
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
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 Date July 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP