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A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798135
First Posted: November 25, 2008
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University
Results First Submitted: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Neoplasms
Neoplasm Metastasis
Intervention: Drug: itraconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Itraconazole oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Participant Flow:   Overall Study
    Itraconazole
STARTED   13 
COMPLETED   0 
NOT COMPLETED   13 
Disease progression, relapse                11 
Disease progression, refractory                1 
Physician Decision                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Itraconazole oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Baseline Measures
   Itraconazole 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (14.3) 
Gender 
[Units: Participants]
 
Female   13 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   13 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   12 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   Pharmacokinetics (PK) of Oral Itraconazole   [ Time Frame: pre-dose at Weeks 2 and 4 ]

2.  Secondary:   Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment   [ Time Frame: up to 100 months ]

3.  Secondary:   Time to Progression.   [ Time Frame: up to 100 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kathy Miller, MD
Organization: IndianaU
e-mail: kathmill@iupui.edu



Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00798135     History of Changes
Other Study ID Numbers: 0809-10; IUCRO-0239
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: August 25, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 11, 2015