Clinical trial NCT00071006: AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Official title: Phase 2 Study Of AG-013736 In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-10-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: 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:
measure: Percentage of Participants With Hematologic Improvement (HI)
timeFrame: Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)
measure: Duration of Response (DR)
timeFrame: 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
measure: Bone Marrow Micro Vessel Density (MVD)
timeFrame: Day 1, Week 2 thereafter every 4 weeks up to 35 weeks
measure: Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation
timeFrame: Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)
measure: Plasma Vascular Endothelial Growth Factor (VEGF) Concentration
timeFrame: Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)
measure: Population Pharmacokinetics of Axitinib (AG-013736)
timeFrame: Day 1 (pre-dose) and every 4 weeks up to 35 weeks
measure: Overall Survival (OS)
timeFrame: Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: