Effect of Body Mass on Filgrastim Pharmacokinetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01719432
First received: October 29, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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
Hematological Malignancy
Pharmacokinetics of Filgrastim

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: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese patients
Non-obese patients

  Eligibility

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

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
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

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

No publications provided

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: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Filgrastim
Obese
Non-obese
Pharmacokinetics

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014