An open-label, multicenter, expanded access study of imatinib mesylate in adult patients with GIST in adjuvant setting after R0-resectio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 750

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 < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal
• Male and female patients who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
• Ability to understand and willingness to sign a written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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