To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.

Study Design:

A phase I, open-label, nonrandomized study to determine safety and pharmacokinetics of
belinostat in patients with relapsed/refractory solid tumors or hematological malignancies
and to determine the PK profiles in patients with renal impairment. Eligible patients will be
assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal,
mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild
renal impairment, and dose B for moderate or severe renal impairment.

Enrollment into all cohorts will occur simultaneously rather than sequentially except in the
following instance: Before any patient is enrolled in Cohort D, safety will be assessed for
at least 1 patient in Cohort C through the end of Cycle 6. If the patient in Cohort C
experiences a toxicity that is at least Grade 3 in severity, Cohort D will proceed at a
reduced starting dose.

Belinostat will be administered via a 30-minute intravenous (IV) infusion once daily on Days
1 to 5 of a 21-day cycle (for up to 6 cycles). Clinical safety will be monitored in each
patient, and up to two dose reductions from the starting dose (not less than 250mg/m^2) is
allowed based on pre-defined criteria.

If a patient cannot tolerate the reduced dose due to Grade 3 or 4 toxicity, belinostat
administration must be discontinued. Dose escalation is not allowed. Blood samples for PK
analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be
collected from Day 1 to Day 4.

Inclusion Criteria:

1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy
that is relapsed/refractory, for which no standard salvage therapy exists.

2. Patient must have received at least 1 prior therapy for the current malignancy and has
recovered from any toxicity of the prior therapy at screening.

3. Patient has either normal or impaired renal functions.

4. Patient has adequate hematological and hepatic functions.

Exclusion Criteria:

1. Patient has acute or progressive renal impairment related to disease or any other
cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria,
nephrotic syndrome), or requires dialysis.

2. Patient has acute HBV or HCV

3. Patient has known human immunodeficiency virus (HIV) positive diagnosis.

4. Patient has had previous exposure to belinostat.