CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Doxorubicin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01537029
NCT01537029Phase 4Completed

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

Texas Tech University Health Sciences Center·interventional·Posted Feb 22, 2012·Updated Aug 22, 2018

In Brief

A Phase 4 clinical trial evaluating Doxorubicin and Cyclophosphamide for Breast Cancer and Obesity. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsUniversity of Texas

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartFeb 1, 2012
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.4 years ago

Interventions

Doxorubicindrug

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

Cyclophosphamidedrug

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