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Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide

NCT01537029 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-08-22

Study results available
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Summary

To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.

Conditions

Interventions

DRUG

Doxorubicin

Dosed by the patient's treating physician according to local standard of care.

DRUG

Cyclophosphamide

dosage form: IV, Dosage, frequency, and duration: According to local standard of care

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Ronald G Hall, PharmD · Texas Tech University HSC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537029 on ClinicalTrials.gov