Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
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ClinicalTrials.gov Identifier: NCT00939159 |
Recruitment Status
:
Terminated
(Low Accrual)
First Posted
: July 14, 2009
Results First Posted
: June 18, 2015
Last Update Posted
: June 18, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | July 10, 2009 | |||
First Posted Date ICMJE | July 14, 2009 | |||
Results First Submitted Date | June 3, 2015 | |||
Results First Posted Date | June 18, 2015 | |||
Last Update Posted Date | June 18, 2015 | |||
Study Start Date ICMJE | August 2009 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Response Rate Based on the Hematologic Improvement [ Time Frame: Assessment with 28-day cycle until response, then every 3 cycles as needed ] Overall response rate defined by International Working Group (IWG) response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets: absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence . |
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Original Primary Outcome Measures ICMJE |
Overall Response Rate Based on the Hematologic Improvement [ Time Frame: Treatement cycle of 4 weeks ] | |||
Change History | Complete list of historical versions of study NCT00939159 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) | |||
Official Title ICMJE | Phase II Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome | |||
Brief Summary | The goal of this clinical research study is to learn if LBH589 can help to control lower-risk (low or intermediate-1 risk) MDS. The safety of this drug will also be studied. | |||
Detailed Description | Study Drug: LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes (proteins produced by cells). Study Drug Administration: If you are found to be eligible to take part in this study, you will take LBH589 capsules by mouth 3 times a week for 3 weeks (for example on Days 1, 3, 5, 8, 10,12, 15, 17, and 19) then 1 week of rest of each 28-day study "cycle." You should take LBH589 at the same time each morning. Each dose of LBH589 should be taken with 1 cup (8 ounces) of water. You should swallow the capsules whole and not chew them. You must not eat grapefruit and Seville (sour) oranges or drink their juices during your entire participation on the study. If you vomit while taking LBH589, then you should wait until your next scheduled dose to take another capsule. If you forget to take your capsules in the morning, you can take them up to 12 hours after the usual time you take it. After 12 hours, do not take LBH589 that day. Instead, wait until your next scheduled dose. Do not make up missed doses. Call your study doctor or study staff as soon as possible if you have any unusual symptoms. Do not wait until your next visit to tell your doctor about your symptoms. If you have side effects at your assigned dose level, then your dose may be lowered. You may also have to stop taking LBH589 for a short period, and the side effect(s) will be watched by your doctor until they resolve. Take the drug just as the doctor tells you. Do not miss any capsules. You will be asked to return all study drug in the bottles provided, whether your take all the capsules or not. Empty bottles should also be brought back to the clinic. Capsules should not be transferred between bottles at any time. At each visit, you must tell the study staff about any other drugs you are taking during the study. This includes prescription drugs, over-the-counter drugs, and vitamins. Your study doctor will tell you if you need to stop taking any of these drugs. Study Visits: At least every week during Cycle 1 and every cycle after that, you will have the following tests and procedures performed:
On Day 21 (+/- 7 days) of Cycle 1, you will have a bone marrow biopsy/aspirate to check the status of the disease. On Days 1 and 5 of Cycle 1, and Days 5 and 22 of Cycles 2 and beyond, you will have ECGs. If your doctor thinks it is necessary, you may have ECGs more often. On Day 1 of Cycle 2 and beyond you will have EKG prior to taking the study medication. Length of Study: You may continue taking the study drug for up to 24 months. You will be taken off study if intolerable side effects occur or the disease gets worse. End of Study Visit: When you stop taking LBH589, you will have the following tests and procedures performed:
This is an investigational study. LBH589 is not FDA approved or commercially available. At this time, LBH589 is only being used for research. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Myelodysplastic Syndrome | |||
Intervention ICMJE | Drug: LBH589
20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle. |
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Study Arms | Experimental: LBH589
LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
Intervention: Drug: LBH589 |
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Publications * | Dimicoli S, Jabbour E, Borthakur G, Kadia T, Estrov Z, Yang H, Kelly M, Pierce S, Kantarjian H, Garcia-Manero G. Phase II study of the histone deacetylase inhibitor panobinostat (LBH589) in patients with low or intermediate-1 risk myelodysplastic syndrome. Am J Hematol. 2012 Jan;87(1):127-9. doi: 10.1002/ajh.22198. Epub 2011 Nov 10. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
17 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date | June 2013 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00939159 | |||
Other Study ID Numbers ICMJE | 2007-0713 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Collaborators ICMJE | Novartis Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |