CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0619 (clinicaltrials.gov NCT No: NCT00946647)
Title:A phase Ib/IIb, open-label, multi-center study of oral Panobinostat (LBH589) administered with 5-Azacitidine (VidazaŽ) in adult patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML)
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:Azacitidine; Panobinostat
Study Status:Closed
Study Description:The goal of this clinical research study is to find the highest tolerable dose
of panobinostat that can be given in combination with VidazaŽ (azacitidine) to
patients with MDS, CMML, or AML. The safety of this drug combination will also
be studied.

Hide details for General InformationGeneral Information

Disease Group:Leukemia
Phase of Study:Phase I
Treatment Agents:Azacitidine
Panobinostat
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:NA
Supported By:Novartis Pharmaceuticals
Return Visit:Cycle 1: Days 1-10, then every 2-4 days (Days 12, 15, 17, 19, 22, 24, and 28,
possibly Days 35 and 42 as well)
Cycle 2 and beyond: weekly
Home Care:NA


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Physician Name:Guillermo Garcia-Manero
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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