Effect of Body Mass on Filgrastim Pharmacokinetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by West Virginia University
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University
ClinicalTrials.gov Identifier:
First received: October 29, 2012
Last updated: December 11, 2015
Last verified: December 2015

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.

Hematological Malignancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Body Mass on Filgrastim Pharmacokinetics

Resource links provided by NLM:

Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Systemic clearance of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alpha and beta half-life of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Obese patients
Non-obese patients


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese and non-obese patients receiving filgrastim

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
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: NCT01719432

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
Principal Investigator: Aaron Cumpston, PharmD, BCOP West Virginia University
  More Information

Responsible Party: Aaron Cumpston, PharmD, Clinical Specialist - BMT, West Virginia University
ClinicalTrials.gov Identifier: NCT01719432     History of Changes
Other Study ID Numbers: WVU 021112 
Study First Received: October 29, 2012
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:

Additional relevant MeSH terms:
Hematologic Diseases
Leukocyte Disorders
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2016