Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00729482
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : February 13, 2014
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stomach Neoplasm
Intervention Drug: RAD001
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RAD001
Hide Arm/Group Description Treatment Arm (RAD001) take RAD001 10mg/day dose (two 5mg tablets) orally evert day with a glass of water at the same time each day in a fasting state or with a light fat-free meal.
Period Title: Overall Study
Started 54
Completed 54
Not Completed 0
Arm/Group Title RAD001
Hide Arm/Group Description Treatment Arm (RAD001)
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
Baseline analysis was based on all enrolled patients.
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 54 participants
57.5
(27 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
9
  16.7%
Male
45
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 54 participants
54
1.Primary Outcome
Title Progression-free Survival Rate at 4-month (16 Weeks)
Hide Description progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
Time Frame 4 months (16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001
Hide Arm/Group Description:
Treatment Arm (RAD001)
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
18.4
2.Secondary Outcome
Title Response Rate
Hide Description Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
Time Frame 2years
Hide Outcome Measure Data
Hide Analysis Population Description
51 patients were available for response assessments.
Arm/Group Title RAD001
Hide Arm/Group Description:
Treatment Arm (RAD001)
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: percentage of participants
3.7
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001
Hide Arm/Group Description:
Treatment Arm (RAD001)
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: Months
8.3
(4.5 to 12.1)
4.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001
Hide Arm/Group Description:
Treatment Arm (RAD001)
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
54
Time Frame At least 6 months after last dose of chemotherapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAD001
Hide Arm/Group Description Treatment Arm (RAD001)
All-Cause Mortality
RAD001
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RAD001
Affected / at Risk (%)
Total   5/54 (9.26%) 
Cardiac disorders   
Sudden death  1  1/54 (1.85%) 
Gastrointestinal disorders   
Ileus  1 [1]  1/54 (1.85%) 
Gastrointestinal bleeding  1  1/54 (1.85%) 
Infections and infestations   
Pneumonia  1  3/54 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI_CTC_v3.0
[1]
Grade 2 paralytic intestinal obstruction
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAD001
Affected / at Risk (%)
Total   54/54 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  23/54 (42.59%) 
Anemia  1  51/54 (94.44%) 
Thrombocytopenia  1  47/54 (87.04%) 
Hemorrhage  1  18/54 (33.33%) 
Gastrointestinal disorders   
Diarrhea  1  19/54 (35.19%) 
Constipation  1  15/54 (27.78%) 
Anorexia  1  43/54 (79.63%) 
Nausea  1  21/54 (38.89%) 
Stomatitis  1  41/54 (75.93%) 
General disorders   
Asthenia  1  52/54 (96.30%) 
Hepatobiliary disorders   
Hyperbilirubinemia  1  14/54 (25.93%) 
Elevated alkaline phosphatase  1  18/54 (33.33%) 
Elevated aspartate aminotransferase  1  32/54 (59.26%) 
Elevated alanine aminotransferase  1  20/54 (37.04%) 
Elevated gamma glutamyl transpeptidase  1  17/54 (31.48%) 
Metabolism and nutrition disorders   
Hypercholesterolemia  1  24/54 (44.44%) 
Triacylglyceridemia  1  13/54 (24.07%) 
Hyperglycemia  1  47/54 (87.04%) 
Hypophosphatemia  1  14/54 (25.93%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  20/54 (37.04%) 
Renal and urinary disorders   
Hyponatremia  1  24/54 (44.44%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  8/54 (14.81%) 
Skin and subcutaneous tissue disorders   
Skin rash  1  35/54 (64.81%) 
Hand-foot syndrome  1  13/54 (24.07%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI_CTC_v3.0
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
Layout table for Results Point of Contact information
Name/Title: Dr. Yoon-Koo Kang
Organization: Asan Medical Center
Phone: +82-2-3010-3210
EMail: ykkang@amc.seoul.kr
Layout table for additonal information
Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov 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: November 27, 2018