This will be a single arm Phase II study.
LBH589 (20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Panobinostat(20 mg or 30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
Florida Cancer Specialists
Fort Myers, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Overall Response Rate (CR, Marrow CR + PR) of LBH in Patients With Relapsed or Refractory MDS.
Overall response rate (ORR) is defined by the modified International Working Group (IWG) Response Criteria for MDS. In the marrow, Complete Response (CR) is \<= 5% blasts present with normal maturation of all cell lines. In peripheral blood, CR is defined as hemoglobin \>= 11 g/dL, ANC \>= 1000/mL, and platelets \>= 100,000 with 0% blasts present. Partial Response (PR) is defined the same as CR with blasts decreased by \>= 50% and \>= 5% blasts in the marrow.
Time frame: Every 8 weeks up to 24 months on-study.
Time to Disease Progression
Time to disease progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Every 8 weeks up to 24 months on-study, every 3 months in follow-up until progression of disease
Hematologic Improvement, Including Transfusion Independence
Hematologic measures will include total WBC and platelets
Time frame: Every 8 weeks up to 24 months on-study
Duration of Response
Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
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Oncology Hematology Care
Cincinnati, Ohio, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Time frame: Every 8 weeks up to 24 months on-study
Median Time to Treatment Failure
Time to treatment failure is defined as measuring the time between cycle 1 day 1 to discontinuation for any reason.
Time frame: 24 months
Median Overall Survival
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 24 months on-study, patients followed every 3 months in follow-up
Safety and Tolerability of LBH589 in Patients With Relapsed/Refractory MDS by Measuring the Number of Participants With Adverse Events
The reported incidence of AEs and SAEs with an onset on or after the initiation of therapy was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Time frame: 24 months