REGISTER: A multicentre phase 2 study of risk evaluation in GIST with selective therapy escalation for response

REGISTER: A multicentre phase 2 study of risk evaluation in GIST with selective therapy escalation for response

Gastrointestinal Stromal Tumor

Ongoing, but not recruiting

2

Start Date 12/09/2008

Age of Trial (yrs) 15.4

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

REGISTER

AGITG

Karen Bracken 02 9562 5071 registerstudy@ctc.usyd.edu.au karen.bracken@ctc.usyd.edu.au

Oral

The REGISTER Study: A multicentre phase II study of risk evaluation in GIST with selective therapy escalation for response

This is a Phase II, open label, multicentre study evaluating early imatinib dose escalation followed by second-line nilotinib in patients with advanced/metastatic GIST.
Patients will be prospectively stratified to receive early imatinib dose escalation and early switch to nilotinib according to KIT tumour mutation status and early response on FDG-PET scan.

Study Chair: Dr. Jayesh Desai
Royal Melbourne Hospital, Victoria, AUSTRALIA

Project Manager: Reena Gill

Coordinator: Karen Bracken
registerstudy@ctc.usyd.edu.au

Open Date: 9 December 2008

Close Date: Expected recruitment period: 2 years

Current accrual: 6

Target: 80 patients within Australia, New Zealand and South Korea

Summary of eligibility criteria:

▪ Patients with histologically confirmed gastrointestinal stromal tumour, not amenable to surgery with a curative intent
▪ No prior systemic therapy for advanced disease. Patients may enter the study either before commencing imatinib therapy or within the first 6 weeks of imatinib therapy.
▪ Adequate renal and hepatic function
▪ ECOG performance status 0, 1, or 2

Please contact your local site for a complete list of eligibility criteria.