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

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ClinicalTrials.gov Identifier: NCT00798135
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : September 10, 2014
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Indiana University

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
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Itraconazole
Hide Arm/Group Description oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Period Title: Overall Study
Started 13
Completed 0
Not Completed 13
Reason Not Completed
Disease progression, relapse             11
Disease progression, refractory             1
Physician Decision             1
Arm/Group Title Itraconazole
Hide Arm/Group Description oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  53.8%
>=65 years
6
  46.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
59.8  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
13
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
13
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 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
1
   7.7%
White
12
  92.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Pharmacokinetics (PK) of Oral Itraconazole
Hide Description To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.
Time Frame pre-dose at Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with results available.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 2 Intraconazole Concentration 230.7  (216.8)
Week 4 Intraconazole Concentration 305.8  (334.8)
Week 2 6-OH Itraconazole Concentration 454.8  (429.3)
Week 4 6-OH Itraconazole Concentration 501.6  (502.6)
2.Secondary Outcome
Title Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment
Hide Description Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.
Time Frame up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in the study.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
2
3.Secondary Outcome
Title Time to Progression.
Hide Description This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.
Time Frame up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in the study.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: Months
1.54
(0.89 to 2.73)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Itraconazole
Hide Arm/Group Description oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
All-Cause Mortality
Itraconazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Itraconazole
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Gastrointestinal disorders   
NAUSEA *  1/13 (7.69%)  1
PAIN - ABDOMEN NOS *  1/13 (7.69%)  1
VOMITING *  1/13 (7.69%)  1
HEMORRHAGE, GI - UPPER GI NOS *  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
PAIN - BACK *  1/13 (7.69%)  1
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER *  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
PLEURAL EFFUSION (NON-MALIGNANT) *  1/13 (7.69%)  1
Vascular disorders   
THROMBOSIS/THROMBUS/EMBOLISM *  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Itraconazole
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
EDEMA: LIMB *  1/13 (7.69%)  1
Eye disorders   
OCULAR/VISUAL *  1/13 (7.69%)  1
VISION-BLURRED VISION *  1/13 (7.69%)  1
Gastrointestinal disorders   
CONSTIPATION *  5/13 (38.46%)  5
DIARRHEA *  1/13 (7.69%)  1
DISTENSION/BLOATING, ABDOMINAL *  1/13 (7.69%)  1
GASTROINTESTINAL *  1/13 (7.69%)  1
HEARTBURN/DYSPEPSIA *  1/13 (7.69%)  1
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY *  1/13 (7.69%)  1
NAUSEA *  5/13 (38.46%)  5
PAIN - ABDOMEN NOS *  2/13 (15.38%)  2
TASTE ALTERATION (DYSGEUSIA) *  1/13 (7.69%)  1
VOMITING *  1/13 (7.69%)  1
General disorders   
FATIGUE (ASTHENIA, LETHARGY, MALAISE) *  6/13 (46.15%)  6
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) *  3/13 (23.08%)  3
PAIN *  1/13 (7.69%)  1
Hepatobiliary disorders   
BILIRUBIN (HYPERBILIRUBINEMIA) *  1/13 (7.69%)  1
Investigations   
ALKALINE PHOSPHATASE *  1/13 (7.69%)  1
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) *  1/13 (7.69%)  1
HEMOGLOBIN *  2/13 (15.38%)  2
PLATELETS *  1/13 (7.69%)  1
Metabolism and nutrition disorders   
ANOREXIA *  4/13 (30.77%)  4
Musculoskeletal and connective tissue disorders   
PAIN - BACK *  1/13 (7.69%)  1
PAIN - BONE *  2/13 (15.38%)  2
PAIN - EXTREMITY-LIMB *  2/13 (15.38%)  2
PAIN - JOINT *  1/13 (7.69%)  1
Nervous system disorders   
INCONTINENCE, URINARY *  1/13 (7.69%)  1
INSOMNIA *  1/13 (7.69%)  1
NEUROPATHY: CRANIAL - CN VIII HEARING AND BALANCE *  1/13 (7.69%)  1
NEUROPATHY: SENSORY *  2/13 (15.38%)  2
PAIN - HEAD/HEADACHE *  1/13 (7.69%)  1
SPEECH IMPAIRMENT (E.G., DYSPHASIA OR APHASIA) *  1/13 (7.69%)  1
Psychiatric disorders   
INSOMNIA *  4/13 (30.77%)  4
MOOD ALTERATION - ANXIETY *  1/13 (7.69%)  1
MOOD ALTERATION - DEPRESSION *  1/13 (7.69%)  1
Renal and urinary disorders   
URINARY FREQUENCY/URGENCY *  1/13 (7.69%)  1
URINE COLOR CHANGE *  1/13 (7.69%)  1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS *  1/13 (7.69%)  1
Reproductive system and breast disorders   
PAIN - BREAST *  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL *  1/13 (7.69%)  1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS *  1/13 (7.69%)  1
INFECTION WITH UNKNOWN ANC - SINUS *  1/13 (7.69%)  1
PAIN - CHEST WALL *  1/13 (7.69%)  1
COUGH *  2/13 (15.38%)  2
DYSPNEA (SHORTNESS OF BREATH) *  4/13 (30.77%)  4
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE *  1/13 (7.69%)  1
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) *  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS) *  1/13 (7.69%)  1
DERMATOLOGY/SKIN *  1/13 (7.69%)  1
DRY SKIN *  1/13 (7.69%)  1
HAIR LOSS/ALOPECIA (SCALP OR BODY) *  1/13 (7.69%)  1
PRURITUS/ITCHING *  1/13 (7.69%)  1
RASH: ACNE/ACNEIFORM *  2/13 (15.38%)  2
SWEATING (DIAPHORESIS) *  1/13 (7.69%)  1
Vascular disorders   
HOT FLASHES/FLUSHES *  2/13 (15.38%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathy Miller, MD
Organization: IndianaU
EMail: kathmill@iupui.edu
Layout table for additonal information
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