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An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.

Phase 3
18 Years
Not Enrolling
Gastrointestinal Stromal Tumors

Thank you

Trial Information

An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.

This is a multicenter open label clinical trial to be performed in patients with incurable
malignant GISTs that are unresectable or metastatic. Approximately 150 patients will enter
the trial.

Patients will receive Imatinib 400 mg p.o./day for a period of up to 24 months provided that
in the opinion of the investigator the patient is benefiting from treatment with Imatinib,
and in the absence of any safety concerns.

Treatment after completion of the 24 months study is at the discretion of the investigator.
Imatinib should be increased to 600 mg p.o./day and then to 400 mg b.i.d if the patient is
progressing on the respective dose level.

Inclusion Criteria:

- Patients >= 18 years of age

- Histologically documented diagnosis of GIST which is malignant as well as
unresectable (=not amenable to surgery with curative intent) and/or metastatic and
therefore incurable Immunohistochemical documentation of c-kit (CD117) expression by

- At least one measurable site of disease (as defined by Southwestern Oncology Group
Solid Tumor Response Criteria) which has not been previously embolised or irradiated

- Performance status 0,1, 2 or 3 (ECOG)

- Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN,
SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present),
creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L

- Female patients of child-bearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Post menopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing potential.
Male and female patients of reproductive potential must agree to employ an effective
barrier method of birth control throughout the study and for up to 3 months following
discontinuation of study drug

- Life expectancy of at least 6 months

- Written, voluntary, informed consent

- Patients who were previously treated with chemotherapy will be eligible for this

- Patient who are at least 5 years free of melanoma will be eligible for this study

Exclusion Criteria:

- Patient has received any other investigational agents within 28 days of first day of
study drug dosing

- Patient is < 5 years free of another primary malignancy except: if the other primary
malignancy is not currently clinically significant nor requiring active intervention
and CECOGs' approval is obtained, or if other primary malignancy is a basal cell skin
cancer or a cervical carcinoma in situ. Existence of any other malignant disease is
not allowed

- Patient with Grade III/IV cardiac problems as defined by the New York Heart
Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6
months of study)

- Female patients who are pregnant or breast-feeding.

- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled
diabetes, chronic renal disease, or active uncontrolled infection)

- Patient has a known brain metastasis

- Patient has an acute or known chronic liver disease (i.e., chronic active hepatitis,

- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection

- Patient received chemotherapy within 4 weeks (6 weeks for nitrosoureas or
mitomycin-C) prior to study entry

- Patient previously received radiotherapy to >= 25 % of the bone marrow

- Patient had a major surgery within 2 weeks prior to study entry

- Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent

- Therapeutic anticoagulation with warfarin (e.g. Coumadin® or Coumadine®)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Disease Progression

Outcome Time Frame:

until PD

Safety Issue:


Principal Investigator

Thomas Brodowicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Clinic of Internal Medicine I / Clinical Oncology


Austria: Federal Ministry for Health and Women

Study ID:

CECOG/GIST 1.2.001



Start Date:

March 2004

Completion Date:

July 2008

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Stromal Tumors
  • Glivec
  • Gastrointestinal Stromal Tumors