NCT01719432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

8 years

First QC Date

October 29, 2012

Last Update Submit

December 15, 2020

Conditions

Hematological MalignancyNeutropenia

Keywords

FilgrastimObeseNon-obesePharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Systemic clearance of filgrastim in obese and non-obese patients

    24 hours

Secondary Outcomes (4)

  • Alpha and beta half-life of filgrastim in obese and non-obese patients

    24 hours

  • Maximum concentration (Cmax) of filgrastim in obese and non-obese patients

    24 hours

  • Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients

    24 hours

  • Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients

    24 hours

Study Arms (2)

Obese patients

Non-obese patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese and non-obese patients receiving filgrastim

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

  • Stewart AW, Shillingburg A, Petros W, Wen S, Piktel D, Moses R, Gibson LF, Craig M, Cumpston A. A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls. Pharmacotherapy. 2022 Jan;42(1):53-57. doi: 10.1002/phar.2646. Epub 2021 Nov 22.

    PMID: 34767652DERIVED

MeSH Terms

Conditions

Hematologic NeoplasmsNeutropeniaObesity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aaron Cumpston, PharmD, BCOP

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Specialist - BMT

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

December 5, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

US(1)