Status:
TERMINATED
A Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Patients With Advanced or Refractory Leukemia or Myelodysplastic Syndrome
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Advanced or Refractory Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 pati...
Detailed Description
This is an open-label (all people know the identity of the intervention), Phase 1 dose escalation, 2-part study (Part I and Part II). In Part I of the study, the Maximum Tolerated Dose (MTD) defined a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00676728
Start Date
December 1 2008
End Date
September 1 2011
Last Update
September 14 2012
Active Locations (2)
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1
Baltimore, Maryland, United States
2
Houston, Texas, United States