drugset / Trial / NCT02680795
Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
Phase 1
Completed
17 enrolled
Acrotech Biopharma Inc.
Axis Clinical Trials · collabAxis Clinicals Limited · collab
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2016-04-27
- Primary completion
- 2020-07-21
- Completion
- 2020-07-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belinostat | Small molecule | 750 mg | Intravenous |
| Subject | Belinostat | Small molecule | 1000 mg | Intravenous |