We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

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: NCT01440959
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumors
Intervention: Drug: dovitinib

  Participant Flow

  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.
No text entered.

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   24 
>=65 years   6 
[Units: Years]
Mean (Standard Deviation)
 56.5  (10.4) 
[Units: Participants]
Female   9 
Male   21 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   30 

  Outcome Measures

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 ]

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

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.  

  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
No text entered.

  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
e-mail: ykkang@amc.seoul.kr

Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01440959     History of Changes
Other Study ID Numbers: CTKI258AKR01T
First Submitted: September 8, 2011
First Posted: September 27, 2011
Results First Submitted: November 12, 2013
Results First Posted: March 3, 2014
Last Update Posted: March 3, 2014