Trial Outcomes & Findings for Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation (NCT NCT00278876)

NCT ID: NCT00278876

Last Updated: 2020-01-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2020-01-07

Participant Flow

Forty-eight patients were enrolled at four centers in South Korea between August 2005 and June 2007.

One patient was excluded from the study before treatment initiation because of metastatic disease.

Participant milestones

Measure	Imatinib Mesylate imatinib mesylate 400 mg daily for 2 years
Overall Study STARTED	47
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation

Baseline characteristics by cohort

Measure	Imatinib Mesylate n=47 Participants patients receiving adjuvant imatinib mesylate
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Age, Continuous	56.3 years STANDARD_DEVIATION 10.0 • n=93 Participants
Sex: Female, Male Female	23 Participants n=93 Participants
Sex: Female, Male Male	24 Participants n=93 Participants
Region of Enrollment Korea, Republic of	47 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Imatinib Mesylate n=47 Participants patients receiving adjuvant imatinib mesylate Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
2-year Relapse Free Survival Rate	93.6 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Imatinib Mesylate n=47 Participants patients receiving adjuvant imatinib mesylate Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
2-year Overall Survival Rate	97.9 percentage of participants

SECONDARY outcome

Timeframe: Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.

Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib

Outcome measures

Measure	Imatinib Mesylate n=47 Participants patients receiving adjuvant imatinib mesylate Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
Toxicity Profile	47 participants

Adverse Events

Imatinib Mesylate

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Imatinib Mesylate n=47 participants at risk patients receiving adjuvant imatinib mesylate Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
Blood and lymphatic system disorders Anemia	85.1% 40/47
Blood and lymphatic system disorders Leukopenia	59.6% 28/47
Blood and lymphatic system disorders Neutropenia	72.3% 34/47
Blood and lymphatic system disorders Thrombocytopenia	36.2% 17/47
Musculoskeletal and connective tissue disorders Edema	89.4% 42/47
Musculoskeletal and connective tissue disorders Weight gain	21.3% 10/47
Skin and subcutaneous tissue disorders Dermatitis	57.4% 27/47
Gastrointestinal disorders Anorexia	61.7% 29/47
Gastrointestinal disorders Nausea	48.9% 23/47
Gastrointestinal disorders Vomiting	36.2% 17/47
Gastrointestinal disorders Constipation	10.6% 5/47
Gastrointestinal disorders Diarrhea	55.3% 26/47
Gastrointestinal disorders Dyspepsia	27.7% 13/47
General disorders Asthenia	53.2% 25/47
Psychiatric disorders Insomnia	10.6% 5/47
Respiratory, thoracic and mediastinal disorders Cough	29.8% 14/47
Hepatobiliary disorders Elevated aspartate aminotransferase	25.5% 12/47
Hepatobiliary disorders Elevated alanine transferase	27.7% 13/47
Hepatobiliary disorders Hyperbilirubinemia	29.8% 14/47
Renal and urinary disorders Azotemia	6.4% 3/47

Additional Information

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: ykkang@amc.seoul.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place