AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
NCT00071006
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
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Adult Trials: 18+ Years
- 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
- 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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| 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 |
| |||
| 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 | 12 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||