S9005 Mifepristone in Meningioma
|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: NCT03015701|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Meningioma||Drug: Mifepristone Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma|
|Study Start Date :||August 1992|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||November 2012|
Experimental: Arm 1
Mifepristone 200 mg orally daily for two years
a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor
Other Name: RU-486
Placebo Comparator: Arm 2
Placebo orally daily for two years
placebo matching mifepristone
- Time to Treatment Failure [ Time Frame: 6 years ]
From date of registration to first date of documentation of one of the following:
- Progression (clear worsening of evaluable disease must be confirmed by 2 investigators).
- Significant deterioration of at least one neurologic symptom
- Discontinuation of treatment for any reason.
- Death from any cause.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: two years after beginning treatment ]Patients will be followed for adverse events as defined by the SWOG toxicity criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015701
|Study Director:||Charles Blanke, MD||Oregon Health and Sciences University|