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

History of Changes

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.
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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 ]

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2. Secondary:

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

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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. ]

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4. Secondary:

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

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5. Secondary:

Overall Survival [ Time Frame: Up to 3 years ]

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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

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Other Adverse Events

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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

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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
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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

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

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