A Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Patients With Advanced or Refractory Leukemia or Myelodysplastic Syndrome

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Histone Deacetylase Inhibitors

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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