Relapsed/Refractory Solid Tumors/Hematological Malignancies Clinical Trial
Official title:
An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Mild, Moderate, and Severe Renal Impairment
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies 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.
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.
;