Effect of Body Mass on Filgrastim Pharmacokinetics
This study is currently recruiting participants.
Verified April 2013 by West Virginia University
Sponsor:
Aaron Cumpston, PharmD
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01719432
First received: October 29, 2012
Last updated: April 30, 2013
Last verified: April 2013
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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: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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: Mehdi Hamdani, 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: | April 30, 2013 |
| 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 May 23, 2013