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RAD001 in Recurrent Endometrial Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00087685
First Posted: July 14, 2004
Last Update Posted: February 5, 2016
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.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: December 1, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Endometrial Cancer
Intervention: Drug: RAD001

  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
Recruitment Period: June 18, 2004 to March 20, 2008. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
RAD001 10 mg orally daily/28-day cycles

Participant Flow:   Overall Study
    RAD001
STARTED   35 
COMPLETED   21 
NOT COMPLETED   14 
Adverse Event                5 
Non-Compliance                1 
Progressive Disease                5 
Withdrawal by Subject                3 



  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
RAD001 10 mg orally daily/28-day cycles

Baseline Measures
   RAD001 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Median (Full Range)
 59 
 (38 to 81) 
Gender 
[Units: Participants]
 
Female   35 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures
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1.  Primary:   Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)   [ Time Frame: 8 weeks ]

2.  Primary:   Clinical Benefit Rate   [ Time Frame: 20 weeks ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Karen H. Lu, MD, Chair, Gynecologic Oncology & Reproductive Medicine
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-745-8902
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00087685     History of Changes
Other Study ID Numbers: 2004-0002
NCI-2012-01308 ( Registry Identifier: NCI CTRP )
First Submitted: July 12, 2004
First Posted: July 14, 2004
Results First Submitted: December 1, 2015
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016