Clinical trial · Interventional
AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
Phase 2 Study Of AG-013736 In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)
NCT00071006CI-TRIAL-00007129completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AG-013736 (Axitinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm study
- interventionNames
- Drug: AG-013736 (Axitinib)
Primary outcomes (1)
- 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
- description
- 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.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.