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Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors

NCT00293124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2015-08-13

No results posted yet for this study

Summary

The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data.

Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries.

Conditions

Interventions

DRUG

Glivec

400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing

Sponsors & Collaborators

  • Central European Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Thomas Brodowicz, MD · University Clinic of Internal Medicine I / Clinical Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2006-07-31
Completion
2008-07-31

Countries

  • Austria
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Czechia
  • Lithuania
  • Romania
  • Serbia
  • Slovakia
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00293124 on ClinicalTrials.gov