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

Inclusion Criteria1

Documented diagnosis of GIST with kit expression. 2. At lease one measureable or evaluable site of disease. 3. Performance status 0,1,2 or 3 (ECOG).

Exclusion Criteria1

Patient has received chemotherapy or any other investigational agent within in last 28 days 2. Patient with Grade III/IV cardiac problems 3. Known brain metastasis

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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.