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Trial record 1 of 10 for:    Pharmacokinetics of Belinostat
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To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.

This study is currently recruiting participants.
Verified March 2017 by Spectrum Pharmaceuticals, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02679131
First Posted: February 10, 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
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.

Condition Intervention Phase
Relapsed/Refractory Solid Tumors/Hematological Malignancies 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 Mild, Moderate, and Severe Renal Impairment

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 measure 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 Safety of belinostat in patients with renal impairment [ Time Frame: 26 weeks ]
    Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03

  • Assess Safety of belinostat in patients with renal impairment [ Time Frame: 26 weeks ]
    Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing


Estimated Enrollment: 24
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: Cohort A
Normal Renal function, Belinostat IV, Dose A
Drug: Belinostat
Belinostat will be administered once daily on days 1 to 5 of a 21-day cycle (up to 6 cycles) via 30-min. IV infusion.
Other Name: Beleodaq
Experimental: Cohort B
Mild Impairment, Belinostat IV, Dose A
Drug: Belinostat
Belinostat will be administered once daily on days 1 to 5 of a 21-day cycle (up to 6 cycles) via 30-min. IV infusion.
Other Name: Beleodaq
Experimental: Cohort C
Moderate Impairment, Belinostat IV, Dose B
Drug: Belinostat
Belinostat will be administered once daily on days 1 to 5 of a 21-day cycle (up to 6 cycles) via 30-min. IV infusion.
Other Name: Beleodaq
Experimental: Cohort D
Severe Impairment, Belinostat IV, Dose B
Drug: Belinostat
Belinostat will be administered once daily on days 1 to 5 of a 21-day cycle (up to 6 cycles) via 30-min. IV infusion.
Other Name: Beleodaq

Detailed Description:

Study Design:

A phase I, open-label, nonrandomized study to determine safety and pharmacokinetics of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies and to determine the PK profiles in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.

Enrollment into all cohorts will occur simultaneously rather than sequentially except in the following instance: Before any patient is enrolled in Cohort D, safety will be assessed for at least 1 patient in Cohort C through the end of Cycle 6. If the patient in Cohort C experiences a toxicity that is at least Grade 3 in severity, Cohort D will proceed at a reduced starting dose.

Belinostat will be administered via a 30-minute intravenous (IV) infusion once daily on Days 1 to 5 of a 21-day cycle (for up to 6 cycles). Clinical safety will be monitored in each patient, and up to two dose reductions from the starting dose (not less than 250mg/m^2) is allowed based on pre-defined criteria.

If a patient cannot tolerate the reduced dose due to Grade 3 or 4 toxicity, belinostat administration must be discontinued. Dose escalation is not allowed. 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

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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 therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
  3. Patient has either normal or impaired renal functions.
  4. Patient has adequate hematological and hepatic functions.

Exclusion Criteria:

  1. Patient has acute or progressive renal impairment related to disease or any other cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria, nephrotic syndrome), or requires dialysis.
  2. Patient has acute HBV or HCV
  3. Patient has known human immunodeficiency virus (HIV) positive diagnosis.
  4. 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): NCT02679131


Contacts
Contact: Karen McKenna, MD 949-743-9332 karen.mckenna@sppirx.com
Contact: Chander Vasandai 949-743-9284 chander.vasandani@sppirx.com

Locations
United States, California
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Imran Qasim    562-693-4477      
Principal Investigator: Richy Agajanian, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-491-9763      
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: NCT02679131     History of Changes
Other Study ID Numbers: SPI-BEL-105
First Submitted: January 27, 2016
First Posted: February 10, 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:
relapsed/refractory solid tumors
beleodaq
renal impairment
belinostat
hematological malignancies

Additional relevant MeSH terms:
Neoplasms
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Belinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action