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Trial record 2 of 10 for:    Pharmacokinetics of Belinostat

To Evaluate the Safety and Pharmacokinetics of Belinostat in Patients Who Have Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes

This study is currently recruiting participants.
Verified March 2017 by Spectrum Pharmaceuticals, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02680795
First Posted: February 12, 2016
Last Update Posted: October 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
  Purpose
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 Intervention Phase
Solid Tumors Hematological Malignancies Drug: Belinostat IV Drug: Belinostat Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for steady state volume of distribution (Vdss)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for total body clearance (CLtot)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for fraction excreted unchanged (fe)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for renal clearance (CLren)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for non-renal clearance (CLnonren)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for peak concentration (Cmax)

  • Plasma and urine concentrations of belinostat will be measured [ Time Frame: 26 Weeks ]
    PK will be measured for half-life (t 1/2)


Secondary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 18
Study Start Date: March 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wild Type UGT1A1

Cohort A:

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.

Other Name: Beleodaq
Experimental: Heterozygous UGT1A1*28

Cohort B:

Heterozygous UGT1A1, Belinostat IV

Drug: Belinostat IV

Cohort B:

Belinostat 1000mg 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:

Homozygous UGT1A1, Belinostat IV

Drug: Belinostat

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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Contact: Karen McKenna 949-743-9332 karen.mckenna@sppirx.com
Contact: Chander Vasandani 949-743-9284 chander.vasandani@sppirx.com

Locations
United States, California
The Oncology Institute of Hope and Innovation Recruiting
Whittier, California, United States
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
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Nawazish Khan, MD Spectrum Pharmaceuticals, Inc
  More Information

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02680795     History of Changes
Other Study ID Numbers: SPI-BEL-106
First Submitted: February 9, 2016
First Posted: February 12, 2016
Last Update Posted: October 18, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Spectrum Pharmaceuticals, Inc:
UGT1A1*28
Belinostat
beleodaq
wild type genotypes
heterozygous genotypes
homozygous genotypes

Additional relevant MeSH terms:
Neoplasms
Belinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action