RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment

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: NCT00729482
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stomach Neoplasm
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
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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
RAD001 Treatment Arm (RAD001)

Participant Flow:   Overall Study

  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.
Baseline analysis was based on all enrolled patients.

Reporting Groups
RAD001 Treatment Arm (RAD001)

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
Age, Customized 
[Units: Years]
Median (Full Range)
Age_median   57.5 
 (27 to 72) 
[Units: Participants]
Female   9 
Male   45 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   54 

  Outcome Measures

1.  Primary:   Progression-free Survival Rate at 4-month (16 Weeks)   [ Time Frame: 4 months (16 weeks) ]

2.  Secondary:   Response Rate   [ Time Frame: 2years ]

3.  Secondary:   Overall Survival   [ Time Frame: 1 year ]

4.  Secondary:   Toxicity Profiles (According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0)   [ Time Frame: up to 24 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:  
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. Yoon-Koo Kang
Organization: Asan Medical Center
phone: +82-2-3010-3210

Responsible Party: Yoon-Koo Kang, Asan Medical Center Identifier: NCT00729482     History of Changes
Other Study ID Numbers: AMC-ONCGI-0801
First Submitted: August 4, 2008
First Posted: August 7, 2008
Results First Submitted: December 31, 2013
Results First Posted: February 13, 2014
Last Update Posted: February 13, 2014