Table 1.

LBH589 dose levels and possibly related grade 3 or 4 adverse events

Dose level (mg/m2)Dose level sequence*No. patients treatedPatients receiving all dosesNo. DLT patients
4.81330
7.22310
9.03110
11.55321
14.04513
NCI-CTCAE criteria
Grade 3, n = 15 (dose, mg/m2)
Grade 4, n = 7 (dose, mg/m2)
Hepatic
    Elevated ALT1 (11.5)
Blood/bone marrow
    Thrombocytopenia1 (14.0)
    Neutropenia1 (11.5)
    Anemia1 (11.5)
Cardiac
    QTcF prolongation4 (11.5, 14.0—3 pts)*
    Pericardial effusion1 (14.0)
Metabolic/laboratory
    Hypokalemia1 (14.0)
  • * Indicates chronological order dose levels were tested.

  • Received at least six of the scheduled seven doses of LBH589 administered over ≤9 days with no more than 72 hours between doses.

  • Two patients received five of the seven scheduled doses before experiencing grade 2 LBH589-related adverse events (atrial fibrillation and QTcB prolongation, respectively) that did not meet the protocol definition of DLT.