Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes

• Status: Completed
• Trial end date: 2020-07-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma LLC; Spectrum Pharmaceuticals, Inc
• Collaborator: Axis Clinicals Limited
• Treatments: Belinostat

Criteria

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 systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.

3. Patient has adequate hematological and hepatic functions.

Exclusion Criteria:

1. Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening.

2. Patient has HBV or HCV

3. Patient has a known HIV positive diagnosis.

4. Patient has congestive heart failure Class III/IV

5. Patient has had previous exposure to belinostat.