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

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. 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
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period May 2006-May 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Rosiglitazone Rosiglitazone maleate :

Participant Flow:   Overall Study
Adverse Event                1 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
Rosiglitazone Rosiglitazone maleate :

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
[Units: Participants]
Female   2 
Male   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   1 
More than one race   0 
Unknown or Not Reported   0 

  Outcome Measures

1.  Primary:   Number of Responders   [ Time Frame: 7 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
Recruitment was a major limitation. Patients were available but were not interested in the study due to possible side effects of the study drug.

  More Information

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 Identifier: NCT00612066     History of Changes
Other Study ID Numbers: CDR0000586468
P30CA016042 ( U.S. NIH Grant/Contract )
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