Trials / Completed
CompletedNCT00357162
Belinostat in Treating Patients With Myelodysplastic Syndromes
Phase II Study of the Histone Deacetylase Inhibitor PXD101 for the Treatment of Myelodysplastic Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well belinostat works in treating patients with myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Detailed description
OBJECTIVES: I. Establish the efficacy and safety of PXD101 (belinostat) in patients with myelodysplastic syndromes that progressed after or is ineligible for azacitidine treatment. II. Assess the biological activity of PXD101 in these patients via assays of histone acetylation, gene expression profiling, and DNA methylation. OUTLINE: This is a multicenter study. Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or hematologic improvement after 4 courses receive 4 additional courses of therapy. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
Conditions
- de Novo Myelodysplastic Syndromes
- Previously Treated Myelodysplastic Syndromes
- Secondary Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | belinostat | Given IV |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2006-07-27
- Last updated
- 2014-05-20
- Results posted
- 2013-03-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00357162. Inclusion in this directory is not an endorsement.