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

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ClinicalTrials.gov Identifier: NCT02680795
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Axis Clinicals Limited
Information provided by (Responsible Party):
Acrotech Biopharma LLC

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 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
Study Start Date : March 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Belinostat

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




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



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.

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


Contacts
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Contact: Melissa Brugard, CTM, MSW 218.284.9863 m.burgard@axisclinicals.com

Locations
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United States, California
John Wayne Cancer Institute @ Providence Saint John's Health Center Active, not recruiting
Santa Monica, California, United States, 90404
The Oncology Institute of Hope and Innovation Recruiting
Whittier, California, United States, 90603
Contact: Kirsten Bettino    562-693-4477      
Principal Investigator: Richy Agajanian, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-492-3345      
Principal Investigator: Nashat Gabrail, MD         
Sponsors and Collaborators
Acrotech Biopharma LLC
Axis Clinicals Limited
Investigators
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Study Director: Nawazish Khan, MD Acrotech Biopharma LLC

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Responsible Party: Acrotech Biopharma LLC
ClinicalTrials.gov Identifier: NCT02680795     History of Changes
Other Study ID Numbers: SPI-BEL-106
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Acrotech Biopharma LLC:
UGT1A1*28
Belinostat
beleodaq
wild type genotypes
heterozygous genotypes
homozygous genotypes
Additional relevant MeSH terms:
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Neoplasms
Belinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action