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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01084330




Registration number
NCT01084330
Ethics application status
Date submitted
5/03/2010
Date registered
10/03/2010
Date last updated
10/12/2020

Titles & IDs
Public title
Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer
Scientific title
A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy
Secondary ID [1] 0 0
2009-015407-47
Secondary ID [2] 0 0
CAUY922A2202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Gastric Cancer 0 0
Gastro-esophageal Junction Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AUY922
Treatment: Drugs - Docetaxel
Treatment: Drugs - Irinotecan

Experimental: AUY922 -

Active comparator: Docetaxel or Irinotecan -


Treatment: Drugs: AUY922
70mg/m2

Treatment: Drugs: Docetaxel
Docetaxel 75mg/m2

Treatment: Drugs: Irinotecan
Iriniotecan 350mg/m2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary outcome [1] 0 0
Estimate of the Overall Survival Treatment Effect to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Timepoint [1] 0 0
21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary outcome [2] 0 0
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Timepoint [2] 0 0
21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary outcome [3] 0 0
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922
Timepoint [3] 0 0
21 day cycle: treatment until death, lost to follow up or withdrawal

Eligibility
Key inclusion criteria
* Radiologically confirmed advanced gastric cancer
* One previous line of chemotherapy
* Progressive disease
* One measurable lesion
* Blood tests within protocol ranges
* (WHO) Performance Status = 1
* Able to sign informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No symptomatic brain metastases
* No coumarin type anticoagulants
* No liver or kidney disease
* No impaired heart function
* No pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
Bordeaux Cedex
Country [8] 0 0
France
State/province [8] 0 0
Lyon Cedex
Country [9] 0 0
France
State/province [9] 0 0
Toulouse Cedex 9
Country [10] 0 0
Germany
State/province [10] 0 0
Erlangen
Country [11] 0 0
Germany
State/province [11] 0 0
Ulm
Country [12] 0 0
Italy
State/province [12] 0 0
GE
Country [13] 0 0
Italy
State/province [13] 0 0
MO
Country [14] 0 0
Italy
State/province [14] 0 0
PI
Country [15] 0 0
Italy
State/province [15] 0 0
RM
Country [16] 0 0
Italy
State/province [16] 0 0
Napoli
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gyeonggi-do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Korea
Country [19] 0 0
Netherlands
State/province [19] 0 0
Utrecht
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Moscow
Country [21] 0 0
Singapore
State/province [21] 0 0
Singapore
Country [22] 0 0
Switzerland
State/province [22] 0 0
Bellinzona
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taoyuan/ Taiwan ROC
Country [24] 0 0
Taiwan
State/province [24] 0 0
Tainan
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taipei
Country [26] 0 0
Turkey
State/province [26] 0 0
Ankara
Country [27] 0 0
United Kingdom
State/province [27] 0 0
England
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Surrey
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Glasgow
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01084330