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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
A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT01084330
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01084330