Trials / Unknown
UnknownNCT01298934
LBH589 (Panobinostat) for the Treatment of Myelofibrosis
A Phase I/II Open Label Study of LBH589, a Novel Histone Deacetylase Inhibitor (HDACi), in Patients With Primary Myelofibrosis (PMF) and Post-polycythemia/Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Ronald Hoffman · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2011-02-18
- Last updated
- 2015-03-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01298934. Inclusion in this directory is not an endorsement.