Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000392369
Ethics application status
Approved
Date submitted
22/07/2008
Date registered
4/08/2008
Date last updated
22/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response
Scientific title
The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response including treatment with imatinib (400 - 800mg/day) followed by nilotinib (800mg/day)
Secondary ID [1] 253272 0
REGISTER
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumour (GIST) 3440 0
Condition category
Condition code
Cancer 3594 3594 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3173 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Historical

Outcomes
Primary outcome [1] 4496 0
Time to ultimate disease progression on study treatment (using Response Evaluation Criteria in Solid Tumors (RECIST criteria)) for the exon 9/WT subgroup of patients
Timepoint [1] 4496 0
Every 3 months while on study treatment. Study treatment will continue until disease progression on nilotinib.
Secondary outcome [1] 7604 0
Time to ultimate disease progression on study treatment (using Response Evaluation Criteria in Solid Tumors (RECIST criteria)) for the exon 11 subgroup of patients
Timepoint [1] 7604 0
Every 3 months while on study treatment. Study treatment will continue until disease progression.
Secondary outcome [2] 7605 0
Safety and tolerability of imatinib and nilotinib. Safety and tolerability will be assessed and monitored by the study nurse or doctor at each patient visit and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCICTCAEv3.0).
Timepoint [2] 7605 0
Every 2 weeks when commencing new treatment regime. Every 3 months when treatment regimen is established. Assessments will continue until the patient leaves the trial or the patient experiences progressive disease.
Secondary outcome [3] 7606 0
Correlation between pharmacokinetic (serum imatinib levels) and pharmacodynamic (Fluorodeoxyglucose Positron Emission Tomography (FDG PET)scan) measures.
Timepoint [3] 7606 0
At 6 weeks and then every 3 months until treatment with imatinib is ceased.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current gastroinestinal disease that may affect ability to absorb imatinib.
Pregnant or breastfeeding.
Impaired cardiac function.
Use of warfarin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2008
Actual
9/12/2008
Date of last participant enrolment
Anticipated
Actual
31/03/2012
Date of last data collection
Anticipated
Actual
30/04/2014
Sample size
Target
80
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS
Recruitment hospital [1] 10452 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 10453 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 10454 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [4] 10455 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 10456 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 10457 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 10458 0
Border Medical Oncology - Albury
Recruitment hospital [8] 10459 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 10460 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 10461 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [11] 10462 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 10463 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 22161 0
2031 - Randwick
Recruitment postcode(s) [2] 22162 0
2298 - Waratah
Recruitment postcode(s) [3] 22163 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 22164 0
3050 - Parkville
Recruitment postcode(s) [5] 22165 0
3000 - Melbourne
Recruitment postcode(s) [6] 22166 0
3128 - Box Hill
Recruitment postcode(s) [7] 22167 0
2640 - Albury
Recruitment postcode(s) [8] 22168 0
5042 - Bedford Park
Recruitment postcode(s) [9] 22169 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 22170 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 22171 0
7000 - Hobart
Recruitment postcode(s) [12] 22172 0
2605 - Garran
Recruitment outside Australia
Country [1] 1050 0
New Zealand
State/province [1] 1050 0
Auckland, Wellington, Canterbury, Manawatu
Country [2] 10236 0
Singapore
State/province [2] 10236 0
N/A

Funding & Sponsors
Funding source category [1] 3623 0
Other Collaborative groups
Name [1] 3623 0
Australiasian Gastrointestinal Trials Group (AGITG)
Country [1] 3623 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AGITG
Address
Locked Bag 77,
Camperdown 1450
Country
Australia
Secondary sponsor category [1] 3258 0
None
Name [1] 3258 0
Address [1] 3258 0
Country [1] 3258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5675 0
SSWSAHS Ethics Committee (RPAH zone)
Ethics committee address [1] 5675 0
c/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 5675 0
Australia
Date submitted for ethics approval [1] 5675 0
16/05/2008
Approval date [1] 5675 0
10/07/2008
Ethics approval number [1] 5675 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28770 0
Dr Jayesh Desai
Address 28770 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 3050
Country 28770 0
Australia
Phone 28770 0
+61 3 9656 1111
Fax 28770 0
Email 28770 0
[email protected]
Contact person for public queries
Name 11927 0
Ms REGISTER Trial Coordinator
Address 11927 0
NHMRC CTC
Locked Bag 77
Camperdown NSW 1450
Country 11927 0
Australia
Phone 11927 0
+61 2 9562 5000
Fax 11927 0
+61 2 9562 5094
Email 11927 0
[email protected]
Contact person for scientific queries
Name 2855 0
Ms REGISTER Trial Coordinator
Address 2855 0
NHMRC CTC
Locked Bag 77
Camperdown NSW 1450
Country 2855 0
Australia
Phone 2855 0
+61 2 9562 5000
Fax 2855 0
+61 2 9562 5094
Email 2855 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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