Phase 2
N=21
Belinostat in Treating Patients With Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes · Previously Treated Myelodysplastic Syndromes · Secondary Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00357162 ↗Enrolled (actual)
21
Serious AEs
47.6%
Results posted
Mar 2013
Primary outcome: Primary: Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart — 1; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- belinostat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart |
1; 0; 0 | — |
| SECONDARY Time to Progression |
14.9 | — |
| SECONDARY Overall Survival |
17.9 | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Toxicity of Belinostat in Patients With Myelodysplastic Syndrome |
13; 11; 5; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed myelodysplastic syndromes (MDS)
- De novo or secondary MDS
- Patients with 12 weeks
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 2 times ULN
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
- No HIV positivity
- QTc interval ≤ 500 msec
- No long QT syndrome
- No significant cardiovascular disease, including any of the following:
- Unstable angina pectoris
- Uncontrolled hypertension
- Congestive heart failure related to primary cardiac disease
- Condition requiring anti-arrhythmic therapy
- Ischemic or severe valvular heart disease
- Myocardial infarction within the past 6 months
- No other uncontrolled serious medical condition (e.g., cardiac arrhythmias or diabetes)
- Recovered from prior therapy
- No more than 2 prior therapies for MDS
- Prior hematopoietic growth factors, androgens, and other supportive care agents allowed and are not considered in the prior therapy total
- No prior allogeneic stem cell transplantation
- More than 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- No prior histone deacetylase (HDAC) inhibitors for treatment of MDS
- More than 2 weeks since prior valproic acid or other HDAC inhibitors
- No other concurrent investigational agents
- No concurrent medication that may cause torsades depointes, including any of the following:
- Disopyramide
- Dofetilide
- Ibutilide
- Procainamide
- Quinidine
- Sotalol
- Bepridil
- Methadone
- Amiodarone hydrochloride
- Arsenic trioxide
- Cisapride
- Calcium-channel blockers (e.g., lidoflazine)
- Anti-infective agents (i.e., clarithromycin, erythromycin, halofantrine, pentamidine, or sparfloxacin)
- Domperidone or droperidol
- Antipsychotic agents (i.e., chlorpromazine, haloperidol, mesoridazine, thioridazine, or pimozide)
Data sourced from ClinicalTrials.gov (NCT00357162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.