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

This study has been completed.
Information provided by (Responsible Party):
Indiana University Identifier:
First received: November 24, 2008
Last updated: August 28, 2015
Last verified: August 2015
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: 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
Itraconazole oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Participant Flow:   Overall Study
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
Itraconazole oral itraconazole 200mg a day until disease progression or unacceptable toxicities.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   6 
[Units: Years]
Mean (Standard Deviation)
 59.8  (14.3) 
[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

Responsible Party: Indiana University Identifier: NCT00798135     History of Changes
Other Study ID Numbers: 0809-10; IUCRO-0239
Study First Received: November 24, 2008
Results First Received: August 25, 2014
Last Updated: August 28, 2015