Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer
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
2 other identifiers
interventional
68
14 countries
36
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 10, 2020
August 1, 2020
2.1 years
March 5, 2010
December 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary Outcomes (3)
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.
21 day cycle: treatment until death, lost to follow up or withdrawal
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
21 day cycle: treatment until death, lost to follow up or withdrawal
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922
21 day cycle: treatment until death, lost to follow up or withdrawal
Study Arms (2)
AUY922
EXPERIMENTALDocetaxel or Irinotecan
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No symptomatic brain metastases
- No coumarin type anticoagulants
- No liver or kidney disease
- No impaired heart function
- No pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
USC/Kenneth Norris Comprehensive Cancer Center USC/Norris
Los Angeles, California, 90033, United States
University of California at Los Angeles Dept. of UCLA (4)
Los Angeles, California, 90095, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
Baltimore, Maryland, 21287-0013, United States
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
Lake Success, New York, 11042, United States
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
Dallas, Texas, 75246, United States
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, 75702, United States
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
Novartis Investigative Site
Montreal, Quebec, H3G 1A4, Canada
Novartis Investigative Site
Bordeaux, 33075, France
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Lyon, 69373, France
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Toulouse, 31059, France
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Erlangen, 91054, Germany
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Ulm, 89081, Germany
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Genova, GE, 16132, Italy
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Modena, MO, 41100, Italy
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Pisa, PI, 56100, Italy
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Roma, RM, 00168, Italy
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Napoli, 80131, Italy
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Utrecht, 3584CX, Netherlands
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Moscow, 115478, Russia
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Moscow, 129128, Russia
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Singapore, 169610, Singapore
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Suwon, Gyeonggi-do, 442-723, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, 443-380, South Korea
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Seoul, Korea, 05505, South Korea
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Bellinzona, 6500, Switzerland
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Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305, Taiwan
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Tainan, 704, Taiwan
Novartis Investigative Site
Taipei, 10048, Taiwan
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Taipei, Taiwan
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Ankara, 06500, Turkey (Türkiye)
Novartis Investigative Site
Surrey, England, GU2 7XX, United Kingdom
Novartis Investigative Site
Sutton, Surrey, SM2 5PT, United Kingdom
Novartis Investigative Site
Glasgow, G12 0YN, United Kingdom
Novartis Investigative Site
Leicester, LE7 5WW, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2010
First Posted
March 10, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
December 10, 2020
Record last verified: 2020-08