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

NCT02680795 | Completed Phase 1

• 1 other identifier: SPI-BEL-106
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Solid Tumors; Hematological Malignancies

Keywords

UGT1A1*28; Belinostat; beleodaq; wild type genotypes; heterozygous genotypes; homozygous genotypes

Outcome Measures

Primary Outcomes (1)

• Plasma and urine concentrations of belinostat will be measured

  PK will be measured for area under the time-concentration curve (AUC), steady state volume of distribution (Vdss),PK will be measured for total body clearance (CLtot),PK will be measured for fraction excreted unchanged (fe), PK will be measured for renal clearance (CLren), PK will be measured for non-renal clearance (CLnonren), PK will be measured for peak concentration (Cmax),and half-life (t1/2)

  26 Weeks

Secondary Outcomes (2)

• Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03

  26 Weeks

• Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing

  26 Weeks

Study Arms (3)

Wild Type UGT1A1

EXPERIMENTAL

Cohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV

Drug: Belinostat IV

Heterozygous UGT1A1*28

EXPERIMENTAL

Cohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV

Drug: Belinostat IV

Homozygous UGT1A1*28

EXPERIMENTAL

Cohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV

Drug: Belinostat IV

Interventions

Belinostat IV DRUG

Cohort A: Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion. Cohort B: Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion. Cohort C: Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.

Also known as: Beleodaq

Heterozygous UGT1A1*28; Homozygous UGT1A1*28; Wild Type UGT1A1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead
• Axis Clinicals Limited: collaborator
• Axis Clinical Trials: collaborator

Study Sites (3)

John Wayne Cancer Institute @ Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90603, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

belinostat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Wasim Khan, MD

  Acrotech Biopharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 12, 2016
• Study Start: April 27, 2016
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)