RAD001 in Recurrent Endometrial Cancer Patients

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: NCT00087685
Recruitment Status : Completed
First Posted : July 14, 2004
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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
No text entered.

Reporting Groups
RAD001 10 mg orally daily/28-day cycles

Participant Flow:   Overall Study
Adverse Event                5 
Non-Compliance                1 
Progressive Disease                5 
Withdrawal by Subject                3 

  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
RAD001 10 mg orally daily/28-day cycles

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

  Outcome Measures

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

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

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

Responsible Party: M.D. Anderson Cancer Center 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