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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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.


Sponsor: Central European Cooperative Oncology Group

Current Primary Outcome: Time to Disease Progression [ Time Frame: until PD ]

Original Primary Outcome: To assess the clinical and biological activity of Imatinib in patients with unresectable or metastatic malignant GIST, as judged by objective response rates.

Current Secondary Outcome:

  • Time to Disease Progression [ Time Frame: until PD ]
  • Overall Survival [ Time Frame: until death ]


Original Secondary Outcome:

  • To assess the safety and tolerability of Imatinib in this population
  • Time to Disease Progression
  • Overall Survival


Information By: Central European Cooperative Oncology Group

Dates:
Date Received: February 16, 2006
Date Started: March 2004
Date Completion:
Last Updated: August 11, 2015
Last Verified: May 2012