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Compassionate Use of Mifepristone in Brain/Nervous System and Other Cancers

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: NCT00832871
Recruitment Status : Terminated (Low accrual; 4 patients enrolled between 2008-2015)
First Posted : January 30, 2009
Results First Posted : August 2, 2016
Last Update Posted : August 2, 2016
The Feminist Majority Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Cancer
Intervention: Drug: Mifepristone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Reporting Groups

200 mg RU-486 (Mifepristone) daily

Mifepristone: Mifepristone 200 mg will be administered orally

Participant Flow:   Overall Study

  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

200 mg RU-486 (Mifepristone) daily

Mifepristone: Mifepristone 200 mg will be administered orally

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (25 to 64) 
[Units: Participants]
Female   2 
Male   2 
Region of Enrollment 
[Units: Participants]
United States   4 

  Outcome Measures

1.  Primary:   Duration of Response   [ Time Frame: 5 years ]

2.  Secondary:   Toxicity Associated With Adrenal Insufficiency   [ Time Frame: Up to 8 weeks after the end of study treatment ]

3.  Other Pre-specified:   Overall Survival   [ Time Frame: 5 years ]

  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
This is a compassionate use protocol. No statistical analysis was specified in the protocol; it states that only descriptive data will be collected. Data from only 4 patients should not be considered reliable.

  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: Dr. Fa-chyi Lee
Organization: University of New Mexico Comprehensive Cancer Center
phone: 505-925-0405

Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT00832871     History of Changes
Other Study ID Numbers: INST 0817
NCI-2011-02682 ( Registry Identifier: NCI CTRP )
First Submitted: January 29, 2009
First Posted: January 30, 2009
Results First Submitted: June 22, 2016
Results First Posted: August 2, 2016
Last Update Posted: August 2, 2016