Trial Outcomes & Findings for Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide (NCT NCT01537029)

Last Updated: 2018-08-22

Results Overview

Cyclophosphamide analysis was not possible due to rapid drug degradation

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

0-48 hours

Results posted on

2018-08-22

Participant milestones
Measure	Doxorubicin and Cyclophosphamide Doxorubicin: Dosed by the patient's treating physician according to local standard of care. Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Doxorubicin and Cyclophosphamide n=15 Participants Doxorubicin: Dosed by the patient's treating physician according to local standard of care. Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

Timeframe: 0-48 hours

Cyclophosphamide analysis was not possible due to rapid drug degradation

Outcome measures
Measure	Doxorubicin and Cyclophosphamide n=13 Participants Doxorubicin: Dosed by the patient's treating physician according to local standard of care. Cyclophosphamide: dosage form: IV, Dosage, frequency, and duration: According to local standard of care
Clearance (Cl) for Doxorubicin and Cyclophosphamide	1.85 L/hr Interval 0.84 to 4.23

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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