None listed
Conditions
Brief 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.
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.
Sponsors
Novartis Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 criteria
1.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
Outcome results
None listed