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Trial record 46 of 2158 for:    doxorubicin

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

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ClinicalTrials.gov Identifier: NCT01537029
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Breast Cancer
Obesity
Interventions Drug: Doxorubicin
Drug: Cyclophosphamide
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxorubicin and Cyclophosphamide
Hide Arm/Group Description

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

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Doxorubicin and Cyclophosphamide
Hide Arm/Group Description

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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  93.3%
>=65 years
1
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
1
   6.7%
Not Hispanic or Latino
14
  93.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  40.0%
White
9
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Clearance (Cl) for Doxorubicin and Cyclophosphamide
Hide Description Cyclophosphamide analysis was not possible due to rapid drug degradation
Time Frame 0-48 hours
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxorubicin and Cyclophosphamide
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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 Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: L/hr
1.85
(0.84 to 4.23)
Time Frame Pre-dose until last blood draw (24 to 48 hours was the last time point if participant completed all blood draws)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxorubicin and Cyclophosphamide
Hide Arm/Group Description

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

All-Cause Mortality
Doxorubicin and Cyclophosphamide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxorubicin and Cyclophosphamide
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxorubicin and Cyclophosphamide
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ronald Hall
Organization: TTUHSC
Phone: 2143589009
EMail: ronald.hall@ttuhsc.edu
Layout table for additonal information
Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01537029     History of Changes
Other Study ID Numbers: A11-3691
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: July 24, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018