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

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ClinicalTrials.gov Identifier: NCT01440959
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : March 3, 2014
Last Update Posted : March 3, 2014
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: Gastrointestinal Stromal Tumors
Intervention: Drug: dovitinib

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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. ]
  Show Outcome Measure 3

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

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

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

Time Frame Up to 3 years
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    TKI258
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   30/30 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia † 1   
# participants affected / at risk   11/30 (36.67%) 
Anemia † 1   
# participants affected / at risk   15/30 (50.00%) 
Thrombocytopenia † 1   
# participants affected / at risk   13/30 (43.33%) 
Cardiac disorders   
Hypertension † 1   
# participants affected / at risk   13/30 (43.33%) 
Gastrointestinal disorders   
Anorexia † 1   
# participants affected / at risk   10/30 (33.33%) 
Nausea † 1   
# participants affected / at risk   18/30 (60.00%) 
Vomiting † 1   
# participants affected / at risk   12/30 (40.00%) 
Dyspepsia † 1   
# participants affected / at risk   11/30 (36.67%) 
Diarrhea † 1   
# participants affected / at risk   19/30 (63.33%) 
Abdominal pain † 1   
# participants affected / at risk   12/30 (40.00%) 
General disorders   
Asthenia † 1   
# participants affected / at risk   18/30 (60.00%) 
Hepatobiliary disorders   
Elevated aspartate aminotransferase † 1   
# participants affected / at risk   12/30 (40.00%) 
Elevated alanine transaminase † 1   
# participants affected / at risk   14/30 (46.67%) 
Nervous system disorders   
Headache † 1   
# participants affected / at risk   6/30 (20.00%) 
Renal and urinary disorders   
Proteinuria † 1   
# participants affected / at risk   10/30 (33.33%) 
Azotemia † 1   
# participants affected / at risk   18/30 (60.00%) 
Skin and subcutaneous tissue disorders   
Skin rash † 1   
# participants affected / at risk   9/30 (30.00%) 
† Events were collected by systematic assessment
1 Term from vocabulary, NCI_CTCAE version 3.



  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