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PXD101 (Belinostat) in AML
NCT00357032Phase 2
Key facts
- Status
- Completed
- Start
- May 2006
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- belinostat
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of belinostat in acute myeloid leukemia (AML), sponsored by National Cancer Institute. Primary endpoint: Complete Response Rate at 1 year. Started May 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment (belinostat)
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days.
03
Who it enrols
Adult patients with relapsed/refractory AML (age 18+) or newly diagnosed AML (age >60). Patients 18-59 must have had at least one prior induction regimen. Excludes patients with CNS disease, HIV, or significant cardiovascular disease.
04
Endpoints
Primary
Complete Response Rate
Secondary
Overall Survival
Duration of Response
Toxicity Summary
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