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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00729482
First received: August 4, 2008
Last updated: December 31, 2013
Last verified: December 2013
Results First Received: December 31, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stomach Neoplasm
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
No text entered.

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 Treatment Arm (RAD001)

Participant Flow:   Overall Study
    RAD001  
STARTED     54  
COMPLETED     54  
NOT COMPLETED     0  



  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.
Baseline analysis was based on all enrolled patients.

Reporting Groups
  Description
RAD001 Treatment Arm (RAD001)

Baseline Measures
    RAD001  
Number of Participants  
[units: participants]
  54  
Age, Customized  
[units: years]
Median ( Full Range )
 
Age_median     57.5  
  ( 27 to 72 )  
Gender  
[units: participants]
 
Female     9  
Male     45  
Region of Enrollment  
[units: participants]
 
Korea, Republic of     54  



  Outcome Measures
  Show All 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
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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:  
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
e-mail: ykkang@amc.seoul.kr


No publications provided


Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00729482     History of Changes
Other Study ID Numbers: AMC-ONCGI-0801
Study First Received: August 4, 2008
Results First Received: December 31, 2013
Last Updated: December 31, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)