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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12605000138684
Date of registration:	12/08/2005
Prospective Registration:	No
Primary sponsor:	Novartis Australia
Public title:	Advanced GIST
Scientific title:	Phase III, randomised, intergroup, international trial assessing the clinical activity of STI571 at two dose levels in patients with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117)
Date of first enrolment:	13/06/2001
Target sample size:	946
Recruitment status:	Completed
URL:	https://anzctr.org.au/ACTRN12605000138684.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy;
Phase:	Phase 3

Countries of recruitment
Australia	New Zealand	Singapore

Contacts

Name:	Prof Professor John Zalcberg
Address:	School of Public Health Monash University The Alfred Centre 6/99 Commercial Rd Melbourne VIC 3004 Australia
Telephone:	+61 3 9903 0388
Email:	john.zalcberg@petermac.org
Affiliation:

Name:	Ms Advanced GIST trial coordinator
Address:	NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450 Australia
Telephone:	+61 2 9562 5000
Email:	EORTC62005@ctc.usyd.edu.au
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum: Not stated
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Patients with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117);
Patients with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117)

Cancer - Stomach

Intervention(s)

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.

Primary Outcome(s)

To compare the outcome of patients with with unresectable or metastatic gastrointestional stromal tumors (GIST) expressing the kit receptor tyrosine kinase (CD117) treated with low versus high doses of STI571.[After 170 events (progression or death)]

Secondary Outcome(s)

To assess response rates of patients with these two doses of STI571.[After 170 events (progression or death)]

To assess toxicities of patients with these two doses of STI571.[After 170 events (progression or death)]

Secondary ID(s)

National Clinical Trials Registry: NCTR465

European Organisation for Research and Treatment of Cancer (EORTC): EORTC 62005

Source(s) of Monetary Support

EORTC

Novartis Australia

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Royal Prince Alfred Hospital HREC

Status: Approved
Approval date:
Contact:

University of Sydney HREC