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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680795
Recruitment Status : Completed
First Posted : February 12, 2016
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
Axis Clinicals Limited
Information provided by (Responsible Party):
Acrotech Biopharma Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Solid Tumors Hematological Malignancies Drug: Belinostat IV Phase 1

Detailed Description:

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

Enrollment into all cohorts will occur simultaneously rather than sequentially. Belinostat will be administered via a 30-minute infusion once daily from Day 1 to Day 5 of one 21-day cycle. Clinical safety will be monitored in each patient. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Nonrandomized, Phase 1 Study Evaluating Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies in Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
Actual Study Start Date : April 27, 2016
Actual Primary Completion Date : July 21, 2020
Actual Study Completion Date : July 21, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Belinostat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Wild Type UGT1A1
Cohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV
 Drug: Belinostat IV

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.

Other Name: Beleodaq
Experimental: Heterozygous UGT1A1*28
Cohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV
 Drug: Belinostat IV

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.

Other Name: Beleodaq
Experimental: Homozygous UGT1A1*28
Cohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV
 Drug: Belinostat IV

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.

Other Name: Beleodaq


Outcome Measures
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Primary Outcome Measures :
  1. Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    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)


Secondary Outcome Measures :
  1. Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03 [ Time Frame: 26 Weeks ]
    Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1*28 genotypes

  2. Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing [ Time Frame: 26 Weeks ]
    Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1*28 genotypes


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680795


Locations
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United States, California
John Wayne Cancer Institute @ Providence Saint John's Health Center
Santa Monica, California, United States, 90404
The Oncology Institute of Hope and Innovation
Whittier, California, United States, 90603
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Acrotech Biopharma Inc.
Axis Clinicals Limited
Investigators
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Study Director: Wasim Khan, MD Acrotech Biopharma Inc.
More Information
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Responsible Party: Acrotech Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02680795    
Other Study ID Numbers: SPI-BEL-106
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Acrotech Biopharma Inc.:
UGT1A1*28
Belinostat
beleodaq
 wild type genotypes
heterozygous genotypes
homozygous genotypes
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Belinostat
 Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action