The purpose of this study is to confirm the safety and tolerability of oral panobinostat (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Kyoto, Japan
Incidence of Dose Limiting Toxicitiy(DLT)
DLT will be assessed during PK run-in period (up to 7 days) and 1st cycle (28 days)
Time frame: first 5 weeks of treatment period
PK parameter - Cmax
Time frame: Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours
PK parameter - Tmax
Time frame: Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours
PK parameter - AUC (AUC0-48, AUC0-tlast)
Time frame: Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours
PK parameter - T1/2 (apparent oral clearance, volume distribution)
Time frame: Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours
PK parameter - AUC0-inf
Time frame: Day 1 to 3 of PK run-in period; pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours
Trough level of PAN in combination with 5-Aza
Time frame: Day 4, 5, 8 of the 1st cycle; pre-dose (0 hour)
Frequency and severity of Adverse Events (AEs)
Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.
Time frame: Participants will be followed for the duration of treatment, an expected average of 6 months
Laboratory abnormalities
Time frame: duration of treatment, an expected average of 6 months
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