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

This study has been terminated.
(Low accrual; 4 patients enrolled between 2008-2015)
Sponsor:
Collaborator:
The Feminist Majority Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832871
First received: January 29, 2009
Last updated: June 22, 2016
Last verified: June 2016
Results First Received: June 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Cancer
Intervention: Drug: Mifepristone

  Participant Flow
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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
  Description
Mifepristone

200 mg RU-486 (Mifepristone) daily

Mifepristone: Mifepristone 200 mg will be administered orally


Participant Flow:   Overall Study
    Mifepristone  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
Mifepristone

200 mg RU-486 (Mifepristone) daily

Mifepristone: Mifepristone 200 mg will be administered orally


Baseline Measures
    Mifepristone  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median (Full Range)
  45  
  (25 to 64)  
Gender  
[units: participants]
 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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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
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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
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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
e-mail: FLee@salud.unm.edu



Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832871     History of Changes
Other Study ID Numbers: INST 0817
NCI-2011-02682 ( Registry Identifier: NCI CTRP )
Study First Received: January 29, 2009
Results First Received: June 22, 2016
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration