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Effect of Body Mass on Filgrastim Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT01719432
Recruitment Status : Recruiting
First Posted : November 1, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.

Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.


Condition or disease
Hematological Malignancy Neutropenia

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Body Mass on Filgrastim Pharmacokinetics
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Groups and Cohorts

Group/Cohort
Obese patients
Non-obese patients


Outcome Measures

Primary Outcome Measures :
  1. Systemic clearance of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Alpha and beta half-life of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]
  2. Maximum concentration (Cmax) of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]
  3. Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]
  4. Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]

Eligibility Criteria

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
Sampling Method:   Non-Probability Sample
Study Population
Obese and non-obese patients receiving filgrastim
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Receiving filgrastim at 5mcg/kg ± 10%
  • Admitted as an inpatient with an expected stay of at least 24 hours
  • Weight is > 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.
  • Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.

Exclusion Criteria:

  • Patients who have received filgrastim within 24 hours prior to enrollment
  • Patients who have received pegfilgrastim within 14 days prior to enrollment
  • Hypersensitivity reaction to filgrastim or any related product
  • Patients who have taken lithium within 7 days of enrollment
  • Serum Creatinine > 1.5 mg/dL
  • Patients who are pregnant or breastfeeding
  • Patients who are unable to understand and/or render informed consent
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): NCT01719432


Locations
United States, West Virginia
West Virginia University Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Pam Bunner, MT    304-598-4511    bunnerp@wvuhealthcare.com   
Contact: Crystal Street, MT    304-598-4512    streetc@wvuhealthcare.com   
Principal Investigator: Aaron Cumpston, PharmD         
Sub-Investigator: Alexandra Shillingburg, PharmD         
Sub-Investigator: Soumit Basu, MD, PhD         
Sub-Investigator: Michael Craig, MD         
Sub-Investigator: Michael Newton, PharmD         
Sponsors and Collaborators
Aaron Cumpston, PharmD, BCOP
Investigators
Principal Investigator: Aaron Cumpston, PharmD, BCOP West Virginia University
More Information

Responsible Party: Aaron Cumpston, PharmD, BCOP, Clinical Specialist - BMT, West Virginia University
ClinicalTrials.gov Identifier: NCT01719432     History of Changes
Other Study ID Numbers: WVU 021112
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Aaron Cumpston, PharmD, BCOP, West Virginia University:
Filgrastim
Obese
Non-obese
Pharmacokinetics

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs