This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 10 for:    Pharmacokinetics of Belinostat
Previous Study | Return to List | Next Study

To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02679131
First received: January 27, 2016
Last updated: March 10, 2017
Last verified: March 2017
  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: April 2017
Estimated Primary Completion Date: March 2017 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 27, 2016
Last Updated: March 10, 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

ClinicalTrials.gov processed this record on September 21, 2017