Clinical Trial: NCT01537029
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Status:
COMPLETEDPhase:
Phase 4| Lead Sponsor: | Texas Tech University Health Sciences Center |
| Information Provided By: | Texas Tech University Health Sciences Center |
| Last Update Posted: | 2018-08-22 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Doxorubicin
- Drug: Cyclophosphamide
Other Study ID Numbers
- A11-3691
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Texas Tech University Health Sciences Center |
| Information Provided By: | Texas Tech University Health Sciences Center |
| Last Update Posted: | 2018-08-22 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Doxorubicin
- Drug: Cyclophosphamide
Other Study ID Numbers
- A11-3691