CompletedPhase 3ACTRN12605000138684

Advanced GIST

Phase III, randomised, intergroup, international trial assessing the clinical activity of STI571 at two dose levels in patients with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117)

Sponsor

Novartis Australia

Enrollment

946 participants

Start Date

Jun 13, 2001

Study Type

Interventional

Conditions

Patients with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117)

Summary

This is a randomised, open label, multicentre clinical trial of two different doses of imatinib to test whether there is any difference in disease outcome between the doses in patients with unresectable or metastatic malignant gastrointestinal stromal tumours (GIST). Recruitment opened in 2001, closed in 2002 with 946 patients worldwide and 116 at Australian, NZ and Singapore sites. Long term Follow UP closed October 2016.

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This is a clinical study looking at Advanced GIST. It is open to people who have been diagnosed with the condition being studied. Participation typically involves regular medical visits, tests, and following a specific treatment plan.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

It is the study of two doses (400mg and 800mg) of STI571 (Imatinib mesylate) to test whether any relevant dose/activity relationship is detectable in patients with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117). Patients will receive study drug until disease progression or unacceptable toxicity.