Clinical trial · Interventional
A Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Patients With Advanced or Refractory Leukemia or Myelodysplastic Syndrome
A Phase 1 Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Subjects With Advanced or Refractory Leukemia or Myelodysplastic Syndrome
NCT00676728CI-TRIAL-00008021terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Refractory Leukemia | Leukemia | PROBABILISTIC | 0.70 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-26481585 | Drug | Quisinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JNJ-26481585
- interventionNames
- Drug: JNJ-26481585
Primary outcomes (3)
- measure
- Number of patients with adverse events
- timeFrame
- Upto 14 days after last dose administration of study medication
- measure
- Number of patients with dose limiting toxicity [DLT]
- timeFrame
- From the date of dosing upto 3 months after the date the last patient enrolled in Part I of the study, received the first dose of study medication
- description
- Only toxicities that occur during Treatment Cycle 1 will be used for the purposes of defining DLT.
- measure
- Maximum tolerated dose (MTD) of JNJ 26481585
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.