Overview

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

Status:
Terminated
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Acrotech Biopharma LLC
Spectrum Pharmaceuticals, Inc
Collaborator:
Axis Clinicals Limited
Treatments:
Belinostat