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

NCT00278876 | Completed Phase 2 Results

• 2 other identifiers: AMC0501CSTI571BKR08
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

Brief Summary

The presence of c-kit mutation is an independent poor prognostic factor for relapse in addition to large size (\> 5 cm) and high mitotic rate (\> 5/50 high power field \[HPF\]) in localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of high-risk for relapse according to National Institute of Health (NIH) consensus guideline (tumor size \> 10 cm or mitotic count \> 10/50 HPF) also have high-risk of relapse. Until recently, there has been no effective therapy for advanced, unresectable GISTs. However, a new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11 mutation is the strongest prognostic factor for better response and survival. It is reasonable to try imatinib in an earlier and minimal residual status especially for patients at higher risk of relapse and a higher probability of response to imatinib.

Conditions

Sarcoma; Gastrointestinal Stromal Tumors

Keywords

GIST; Imatinib; Adjuvant therapy; Kit mutation

Outcome Measures

Primary Outcomes (1)

• 2-year Relapse Free Survival Rate

  2 years

Secondary Outcomes (2)

• 2-year Overall Survival Rate

  2 years

• Toxicity Profile

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

Study Arms (1)

imatinib mesylate

EXPERIMENTAL

patients receiving adjuvant imatinib mesylate

Drug: Imatinib mesylate (Glivec)

Interventions

Imatinib mesylate (Glivec) DRUG

Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks

imatinib mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117)
• Tumor size \> 5 cm and mitotic rate \> 5/50HPF(High Power Field), or tumor size \> 10 cm irrespective of mitotic rate, or mitotic rate \> 10/50 HPF irrespective of tumor size.
• Presence of mutation in exon 11 of c-kit gene.
• Surgery performed from 3 weeks to 8 weeks before administration of Imatinib mesylate.
• No evidence of residual macroscopic and microscopic disease after surgery.
• Absence of distant metastases
• No prior radiation therapy, no prior chemotherapy, no prior therapy with Imatinib mesylate, or any other molecular targeted or biological therapy.
• Age 18 yrs or older
• ECOG(Eastern Cooperative Oncology Group electrocorticogram) performance status = 0-2
• No New York Heart Association (NYHA) Class 3\~4 cardiac problems
• Absence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as human immunodeficiency virus (HIV) infection, etc.).
• No ongoing pregnancy or nursing..
• No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease-free for 5 years.
• No use of coumarin derivatives at the time of treatment start.
• Adequate liver function, as defined by a serum bilirubin \< 1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 IULN, obtained within 7 days prior to randomization.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (4)

National Cancer Center

Goyang, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Sarcoma; Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Yoon-Koo Kang
• Organization: Asan Medical Center

ykkang@amc.seoul.kr

+82-2-3010-3210

Study Officials

• Yoon-Koo Kang, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: April 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: March 1, 2011
• Last Updated: January 7, 2020
• Results First Posted: July 27, 2015

Record last verified: 2020-01

Locations

KR (4)