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

NCT00676728 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-09-14

No results posted yet for this study

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).

Conditions

Interventions

DRUG

JNJ-26481585

In Part 1, Initial dose of JNJ-26481585 4 mg oral capsule is administered once daily on each day of a 21-day cycle. Dose will be escalated or de-escalated until Maximum tolerated dose (MTD) of JNJ-26481585 is determined in Part 1. MTD of JNJ-26481585 will be the initial dose in Part 2.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676728 on ClinicalTrials.gov