Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 183 for:    RET

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
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
Enrollment 30
Recruitment Details 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 There are no specific approaches between enrollment and treatment.
Arm/Group Title TKI258
Hide Arm/Group Description dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title TKI258
Hide Arm/Group Description dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  80.0%
>=65 years
6
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
56.5  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
9
  30.0%
Male
21
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 30 participants
30
1.Primary Outcome
Title Disease Control Rate (DCR; OR + Stable Disease)
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD

This was evaluated with abdominal and pelvic dynamic CT scan every 4 weeks for the initial 8 weeks, and then every 8 weeks.

Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI258
Hide Arm/Group Description:
dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13
(4.7 to 30.3)
2.Secondary Outcome
Title Overall Response Rate Using Both CT and PET Scans
Hide Description PET scan will be performed at baseline and at 4 weeks of treatment. Metabolic response was defined based on the PET response criteria of the European Organization for Research and Treatment of Cancer (EORTC); a metabolic partial response (mPR) was defined as a 25% reduction in average SUVmax; metabolic stable disease (mSD) between a 25% decrease and 25% increase in average SUVmax; metabolic progressive disease (mPD) as a 25% increase in average SUVmax or the appearance of new uptake in metastatic lesions.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI258
Hide Arm/Group Description:
dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Percentage of participants
Response rate by CT 3
Response rate by PET 13
3.Secondary Outcome
Title Efficacy According to the Primary Mutation Type
Hide Description Correlation between efficacy results such as response, progression-free survival and overall survival, and primary mutation type including KIT exons 9, 11, 13, and 17 and PDGFRα exons 12 and 18.
Time Frame Up to 24weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Efficacy According to the Concentrations of Circulating Growth Factors
Hide Description Correlation between efficacy results, such as response, progression-free survival, and overall survival andcirculating growth factors (including vascular endothelial growth factor, fibroblast growth factor, interleukin‐8, placental growth factor, and fibroblast growth factor23), and soluble receptors (including soluble form of membrane bound vascular endothelial growth factor receptor-1 and -2).
Time Frame Up to 24weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events will be graded according to Common Terminology Criteria for Adverse events version 3.0, up to 3 year.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI258
Hide Arm/Group Description:
dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
30
6.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI258
Hide Arm/Group Description:
dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(3.5 to 3.7)
7.Secondary Outcome
Title Overall Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI258
Hide Arm/Group Description:
dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
9.7
(6.0 to 13.4)
Time Frame Up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TKI258
Hide Arm/Group Description dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
All-Cause Mortality
TKI258
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TKI258
Affected / at Risk (%)
Total   8/30 (26.67%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1 [1]  2/30 (6.67%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1 [2]  1/30 (3.33%) 
QT prolongation  1 [3]  1/30 (3.33%) 
Plumonary thromboembolism  1 [4]  1/30 (3.33%) 
Eye disorders   
Cataract  1 [5]  1/30 (3.33%) 
Gastrointestinal disorders   
Anorexia  1 [6]  1/30 (3.33%) 
Renal and urinary disorders   
Azotemia  1 [7]  1/30 (3.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI_CTCAE version 3.
[1]
Grade 3 thrombocytopenia
[2]
Grade 3 heart failure
[3]
grade 4 QT prolongation
[4]
Grade 3 pulmonary thromboembolism
[5]
Grade 3 cataract
[6]
Grade 2 anorexia
[7]
grade 2 azotemia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TKI258
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  11/30 (36.67%) 
Anemia  1  15/30 (50.00%) 
Thrombocytopenia  1  13/30 (43.33%) 
Cardiac disorders   
Hypertension  1  13/30 (43.33%) 
Gastrointestinal disorders   
Anorexia  1  10/30 (33.33%) 
Nausea  1  18/30 (60.00%) 
Vomiting  1  12/30 (40.00%) 
Dyspepsia  1  11/30 (36.67%) 
Diarrhea  1  19/30 (63.33%) 
Abdominal pain  1  12/30 (40.00%) 
General disorders   
Asthenia  1  18/30 (60.00%) 
Hepatobiliary disorders   
Elevated aspartate aminotransferase  1  12/30 (40.00%) 
Elevated alanine transaminase  1  14/30 (46.67%) 
Nervous system disorders   
Headache  1  6/30 (20.00%) 
Renal and urinary disorders   
Proteinuria  1  10/30 (33.33%) 
Azotemia  1  18/30 (60.00%) 
Skin and subcutaneous tissue disorders   
Skin rash  1  9/30 (30.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI_CTCAE version 3.
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: 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