Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma
The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug will also be studied. The participants' physical state, changes in the size of the tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while on-study will help the researchers decide if LBH589 is safe and effective.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of LBH589, A Novel Oral Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma|
- Determine maximum tolerated dose (MTD) of LBH589 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determine toxicity profile in study population [ Time Frame: 28 days after Cycle 2 Day 1 ] [ Designated as safety issue: Yes ]
- Determine anti-lymphoma activity of LBH589 in (non-CTCL) Hodgkin's and non-Hodgkin's lymphoma patients [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
LBH589 administered orally as once daily dose of 20 mg po q M, W, F on a q 28 day cycle, escalating to a maximum dase of 60 mg
LBH589 will be administered orally as once daily dose of 20 mg po q M, W, F on a q28 day cycle.
This is an open-label, standard 3-3 dose finding scheme with a modification that allows intra-patient dose modification to determine maximum tolerated dose and toxicity profile of LBH589 in patients with recurrent or refractory Hodgkin's or non-Hodgkin's lymphoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032148
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Myron Czuczman, MD||Roswell Park Cancer Institute|