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RAD001 in Recurrent Endometrial Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00087685
First received: July 12, 2004
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
No text entered.

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  
Number of Participants  
[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 )
Study First Received: July 12, 2004
Results First Received: December 1, 2015
Last Updated: January 6, 2016
Health Authority: United States: Food and Drug Administration