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Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01440959
First received: September 8, 2011
Last updated: January 13, 2014
Last verified: January 2014
Results First Received: November 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumors
Intervention: Drug: dovitinib

  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
Between September 2011 and April 2012, a total of 30 patients with metastatic and/or unresectable GISTs who had treatment failure with imatinib and sunitinib were enroled in Asan Medical Center, Seoul, Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There are no specific approaches between enrollment and treatment.

Reporting Groups
  Description
TKI258 dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule

Participant Flow:   Overall Study
    TKI258  
STARTED     30  
COMPLETED     30  
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.
No text entered.

Reporting Groups
  Description
TKI258 dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule

Baseline Measures
    TKI258  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  56.5  ± 10.4  
Gender  
[units: participants]
 
Female     9  
Male     21  
Region of Enrollment  
[units: participants]
 
Korea, Republic of     30  



  Outcome Measures
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1.  Primary:   Disease Control Rate (DCR; OR + Stable Disease)   [ Time Frame: Up to 24 weeks ]

2.  Secondary:   Overall Response Rate Using Both CT and PET Scans   [ Time Frame: Up to 24 weeks ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year. ]

4.  Secondary:   Progression-free Survival   [ Time Frame: Up to 3 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 3 years ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Overall Survival
Measure Description Overall survival duration is calculated as time from the first treatment to the date of death. For patients who are still alive at the cut‐off date for statistical reporting, the overall survival duration will be right censored on the last known alive date.
Time Frame Up to 3 years  
Safety Issue No  

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
TKI258 dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule

Measured Values
    TKI258  
Number of Participants Analyzed  
[units: participants]
  30  
Overall Survival  
[units: months]
Median ( 95% Confidence Interval )
  9.7  
  ( 6.0 to 13.4 )  

No statistical analysis provided for Overall Survival



6.  Secondary:   Efficacy According to the Primary Mutation Type   [ Time Frame: Up to 24weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Efficacy According to the Concentrations of Circulating Growth Factors   [ Time Frame: Up to 24weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: NCT01440959     History of Changes
Other Study ID Numbers: CTKI258AKR01T
Study First Received: September 8, 2011
Results First Received: November 12, 2013
Last Updated: January 13, 2014
Health Authority: Korea: Food and Drug Administration