Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

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.
 
ClinicalTrials.gov Identifier: NCT00887458
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : January 27, 2014
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Itraconazole 200 mg
Drug: Itraconazole 300mg
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Period Title: Overall Study
Started 17 29
Completed 17 25
Not Completed 0 4
Arm/Group Title Low Dose High Dose Total
Hide Arm/Group Description

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Total of all reporting groups
Overall Number of Baseline Participants 17 29 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 29 participants 46 participants
73
(60 to 81)
71
(52 to 89)
73
(52 to 89)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 29 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   5.9%
9
  31.0%
10
  21.7%
>=65 years
16
  94.1%
20
  69.0%
36
  78.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 29 participants 46 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
17
 100.0%
29
 100.0%
46
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 29 participants 46 participants
17 29 46
1.Primary Outcome
Title To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.
Hide Description To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. "PSA progression" is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Based on how many participants were evaluable for the study primary endpoint
Arm/Group Title Low Dose Itraconazole High Dose Itraconazole
Hide Arm/Group Description:

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Overall Number of Participants Analyzed 17 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
11.8
(1.5 to 36.4)
48
(27.8 to 68.7)
2.Secondary Outcome
Title To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.
Hide Description Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.
Time Frame Baseline and approximately 2 years from open enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description:

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Overall Number of Participants Analyzed 17 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
0
(0 to 19.5)
14.3
(4.0 to 32.7)
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose High Dose
Hide Arm/Group Description

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

All-Cause Mortality
Low Dose High Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/29 (0.00%)    
General disorders     
fatigue  1  1/17 (5.88%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/17 (82.35%)      14/29 (48.28%)    
Cardiac disorders     
hypertension  1  0/17 (0.00%)  0 9/29 (31.03%)  9
Gastrointestinal disorders     
anorexia  1  2/17 (11.76%)  2 5/29 (17.24%)  5
General disorders     
fatigue  1  9/17 (52.94%)  9 6/29 (20.69%)  6
Metabolism and nutrition disorders     
hypokalemia  1  0/17 (0.00%)  0 5/29 (17.24%)  5
Skin and subcutaneous tissue disorders     
rash  1  3/17 (17.65%)  3 2/29 (6.90%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Dr. Michael Carducci
Organization: Johns Hopkins University
Phone: 410-614-3977
EMail: carducci@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00887458     History of Changes
Other Study ID Numbers: J0932
JHMI-IRB number: NA_00027099
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: December 11, 2013
Results First Posted: January 27, 2014
Last Update Posted: October 16, 2017