gastrointestinal stromal tumors - adjuvant treatment after surgical tumor resection MedDRA version: 9.1 Level: LLT Classification code 10051066 Term: Gastrointestinal stromal tumour
Conditions
Interventions
Trade Name: Glivec Filmtabletten 400 mg
Product Name: Glivec
Product Code: STI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Imatinib mesylate
CAS Number: 220127-57-1
Current Sponsor
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Histological confirmed diagnosis of GIST with positive immunostaining for KIT (CD117) on a tumor sample taken within 12 weeks of the study entry • Complete gross resection of the tumor • Risk of relapse documented as “intermediate and high” according to NIH criteria: 1. High risk category: - tumor size > 10 cm; or - mitotic rate > 10/50HPF; or - tumor size > 5 cm & mitotic rate > 5/50 HPF 2. Intermediate risk category: - tumor size less than 5 cm & mitotic rate 6-10/50HPF - tumor size 5-10 cm & mitotic rate less than 5/50 HPF • WHO Performance Status 0, 1 or 2 • Patients must have normal organ, electrolyte, and marrow function as defined below: 1. Absolute Neutrophil Count (ANC) = 1.5 x 109/L 2. Platelets = 100 x 109/L 3. Hemoglobin = 10g/dL (or Hematocrit > 29%) 4. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Prior participation in an adjuvant GIST trial • Prior treatment with imatinib • Treatment with any cytotoxic and/or investigational cytotoxic drug = 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1 • Patients with known history of hypersensitivity against imatinib • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs • Use of therapeutic coumarin derivatives (i.e. warfarin, acenoucumarol, phenprocoumon) • Patients who have undergone major surgery = 2 weeks prior to Visit 1 or who have not recovered from side effects of such surgery • A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits • Patients who are pregnant, breast feeding or women of childbearing potential (WOCBP). Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential Women of reproductive potential, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following termination of the study. • Patients unwilling or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of imatinib as measured by rate and severity of adverse events.;Primary end point(s): Safety assessments of the safety analyzable population will be evaluated.;Secondary Objective: To provide patients with GIST in an adjuvant setting with expanded access to imatinib until registration of the drug for this stage of the disease. To explore the relationship of tumor characteristics (KIT and PDGFR mutations) as measured in tumor tissue with clinical outcome for patients where tumor tissue is available. To evaluate the population pharmacokinetics of imatinib. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Spain
Outcome results
None listed