Clinical trial NCT01084330: Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Gastro-esophageal Junction Cancer
Keywords: gastric cancer
metastatic gastric cancer
advanced gastric cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary outcomes:
measure: 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.
timeFrame: 21 day cycle: treatment until death, lost to follow up or withdrawal
measure: Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
timeFrame: 21 day cycle: treatment until death, lost to follow up or withdrawal
measure: Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922
timeFrame: 21 day cycle: treatment until death, lost to follow up or withdrawal
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Comprehensive Cancer Center USC/Norris
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles Dept. of UCLA (4)
state: California
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Baltimore
country: United States
facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
state: Maryland
city: Lake Success
country: United States
facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
state: New York
city: Dallas
country: United States
facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
state: Texas
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Lyon Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Bellinzona
country: Switzerland
facility: Novartis Investigative Site
city: Kuei-Shan Chiang
country: Taiwan
facility: Novartis Investigative Site
state: Taoyuan/ Taiwan ROC
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Surrey
country: United Kingdom
facility: Novartis Investigative Site
state: England
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: