None listed
Conditions
Brief summary
The REGISTER study aims to maximise the treatment potential of Glivec (Registered trade mark) (also known as imatinib) in patients with metastatic or unresectable Gastro-intestinal Stromal Tumour (GIST) by individualising treatment. Treatment for each patient will be determined according to the biological features of their tumour when examined in the laboratory. We know that tumours with certain findings are less likely to do well on standard treatment. Patients with these types of tumours will be treated with an increased dose of Glivec (Registered trade mark). Patients with tumours that we know are more likely to do well will be treated with a standard dose of Glivec (Registered trade mark) but will move on to an increased dose when the standard dose stops being effective. The response to treatment will be measured using Computerized axial Tomography (CT) scans. Early response will be measured using Fluorodeoxyglucose Positron Emission Tomography (FDG PET) scans.
Interventions
Patient treatment regimen will be determined by KIT mutational status. For patients recieving less than or equal to 6 weeks of Imatinib will be classified as either exon 9/WT or exon 11. Patients will initially receive 400mg/day of imatinib (also known as Glivec) administered orally in tablet form. Patients will then receive an escalated dose up to 800mg/day imatinib. The timing of dose escalation will depend on the patient KIT mutational status (exon 9/WT or exon 11) and their early response to
Patient treatment regimen will be determined by KIT mutational status. For patients recieving less than or equal to 6 weeks of Imatinib will be classified as either exon 9/WT or exon 11. Patients will initially receive 400mg/day of imatinib (also known as Glivec) administered orally in tablet form. Patients will then receive an escalated dose up to 800mg/day imatinib. The timing of dose escalation will depend on the patient KIT mutational status (exon 9/WT or exon 11) and their early response to treatment. For patients who have received more than 6 weeks of imatinib they will continue on at a dose of 400mg/day until RECIST-defined progression where the dose will be escalated up to 800mg/day depending on the patient's response to treatment. The rest of the regime will be the same as patients who have received less than or equal to 6 weeks of imatinib treatment.
Sponsors
AGITG
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with metastatic or unresectable GIST. Patients with no prior systemic therapy except 6 weeks or less treatment with imatinib or who have been previously treated with Imatinib but who have had at least 6 months cessation and relapse. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Adequate renal and hepatic function. Patients who have received > 6 weeks of imatinib treatment must be stable for at least 4 weeks at 400mg/day of Imatinib and be evaluable for assessment of objective response according to RECIST criteria.
Exclusion criteria
Current gastroinestinal disease that may affect ability to absorb imatinib. Pregnant or breastfeeding. Impaired cardiac function. Use of warfarin.
Outcome results
None listed