To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.
Stopped early · Phase 1
Conditions studied: Relapsed/Refractory Solid Tumors/Hematological Malignancies
In brief
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.
Key facts
- Study ID
- NCT02679131
- Run by
- Acrotech Biopharma Inc.
- People needed
- 18
- Starts
- 2016-03-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2019-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.
- 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.
- Patient has either normal or impaired renal functions.
- Patient has adequate hematological and hepatic functions.
You may not qualify if…
- 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.
- Patient has acute HBV or HCV
- Patient has known human immunodeficiency virus (HIV) positive diagnosis.
- Patient has had previous exposure to belinostat.
Where it is running
- Innovative Clinical Research Institute — Whittier, California, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
Full record on ClinicalTrials.gov
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