A Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Patients With Advanced or Refractory Leukemia or Myelodysplastic Syndrome
Stopped early · Phase 1
Conditions studied: Advanced or Refractory Leukemia, Myelodysplastic Syndromes
In brief
The purpose of this study is to explore the safety, pharmacokinetic (what the body does to the medication), pharmacodynamic (what the medication does to the body), and activity of JNJ-26481585 in patients with advanced or refractory leukemia and myelodysplastic syndrome (MDS).
Key facts
- Study ID
- NCT00676728
- Run by
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- People needed
- 10
- Starts
- 2008-12-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2012-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed advanced or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia in blast phase, refractory chronic lymphocytic leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
- For Part II, patients with myelodysplastic syndrome
- Eastern Cooperative Oncology Group Performance Status Score 0, 1 or 2
- Left Ventricular Ejection Fraction greater than or equal to 50%
- Negative hepatitis B, C and human immunodeficiency virus (HIV) test within last 3 months
- Adequate liver and kidney function
You may not qualify if…
- Known or suspected involvement of the central nervous system
- Chemotherapy (nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy or treatment with investigative agent within 3 weeks before study drug administration (except hydroxyurea which should be stopped at least 24 hours prior to first dose)
- Unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure
- Poorly controlled hypertension or diabetes, ongoing active infection and psychiatric illness
- Receiving medications known to have a risk of causing QTc prolongation
Where it is running
- Study site — Baltimore, Maryland, United States
- Study site — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.