TRIAL DETAIL

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

Drug:
Trial Name:
REGISTER: A multicentre phase 2 study of risk evaluation in GIST with selective therapy escalation for response
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
2
Start Date 12/09/2008
Age of Trial (yrs) 13
Treatment Phase:
First-line
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
REGISTER
Sponsor:
AGITG
Patient Contact:
Karen Bracken 02 9562 5071 registerstudy@ctc.usyd.edu.au karen.bracken@ctc.usyd.edu.au
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

 
 
 
 
 
 

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
10 St Andrews Place
East Melbourne
Victoria
3002
Australia
Grattan Street
Parkville
Victoria
3050
Australia
49 Palmerston Road
Hornsby
New South Wales
2077
Australia
Barker Street
Randwick
New South Wales
2031
Australia
Edith Street
Waratah
New South Wales
2298
Australia
Powell Street,
Tweed Heads
New South Wales
2485
Australia
Yamba Drive
Garran
Australian Capital Territory
2605
Australia
1 Arnold Street
Box Hill
Victoria
3128
Australia
69 Nordsvan Drive
Wodonga
Victoria
3690
Australia
199 Ipswich Road
Woolloongabba
Queensland
4102
Australia
Flinders Drive
Bedford Park
South Australia
5042
Australia
520 South Road
Kurrulta Park
South Australia
5037
Australia
24 Campbell Street
Hobart
Tasmania
7001
Australia
Christchurch
New Zealand
Palmerston North
New Zealand
Seoul
Songpa-gu
138-736
Republic of Korea
Wellington
New Zealand