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LBH589 (Panobinostat) for the Treatment of Myelofibrosis

NCT01298934 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-03-06

No results posted yet for this study

Summary

LBH589 is an oral drug that targets the myelofibrosis cells in the bone marrow and induces cell death by allowing for the expression of certain suppressed genes that are important in regulating cell survival. Based on laboratory studies, the hypothesis is that this drug will selectively kill the stem cells responsible for causing myelofibrosis and result in reduction in spleen size and ultimately restoration of normal bone marrow function.

Conditions

  • Primary Myelofibrosis
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
  • Post-Essential Thrombocythemia Related Myelofibrosis

Interventions

DRUG

LBH589

Dose escalation study starting at 20mg by mouth three times a week, given weekly for 24 weeks in the phase I portion of the study.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Ronald Hoffman

    lead OTHER

Principal Investigators

  • Ronald Hoffman, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01298934 on ClinicalTrials.gov