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Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)

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ClinicalTrials.gov Identifier: NCT00612066
Recruitment Status : Terminated (Low accrual and funding term ended)
First Posted : February 11, 2008
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cushing's Disease
Intervention Drug: rosiglitazone maleate
Enrollment 2
Recruitment Details Recruitment period May 2006-May 2009
Pre-assignment Details  
Arm/Group Title Rosiglitazone
Hide Arm/Group Description Rosiglitazone maleate :
Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Rosiglitazone
Hide Arm/Group Description Rosiglitazone maleate :
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  50.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Responders
Hide Description

Definition of Treatment Response

  • The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression.
  • Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression).
Time Frame 7 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size was too small to do a valid analysis.
Arm/Group Title Rosiglitazone
Hide Arm/Group Description:
Rosiglitazone maleate :
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rosiglitazone
Hide Arm/Group Description Rosiglitazone maleate :
All-Cause Mortality
Rosiglitazone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rosiglitazone
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rosiglitazone
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
General disorders   
edema in limbs  1/2 (50.00%)  1
Recruitment was a major limitation. Patients were available but were not interested in the study due to possible side effects of the study drug.
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
Name/Title: Anthony Heaney, M.D. Ph.D
Organization: University of California, Los Angeles
Phone: 310 267 4980
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00612066     History of Changes
Other Study ID Numbers: CDR0000586468
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0612080-01
First Submitted: February 8, 2008
First Posted: February 11, 2008
Results First Submitted: January 11, 2013
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016