Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
Completed · Phase 1
Conditions studied: Solid Tumors, Hematological Malignancies
In brief
This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype
Key facts
- Study ID
- NCT02680795
- Run by
- Acrotech Biopharma Inc.
- People needed
- 17
- Starts
- 2016-04-27
- Expected to finish
- 2020-07-21
- Last updated by the study team
- 2025-10-20
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 systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
- Patient has adequate hematological and hepatic functions.
You may not qualify if…
- Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening.
- Patient has HBV or HCV
- Patient has a known HIV positive diagnosis.
- Patient has congestive heart failure Class III/IV
- Patient has had previous exposure to belinostat.
Where it is running
- John Wayne Cancer Institute @ Providence Saint John's Health Center — Santa Monica, California, United States
- The Oncology Institute of Hope and Innovation — Whittier, California, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
Full record on ClinicalTrials.gov
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