Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084330
• Other study ID #: CAUY922A2202
• Secondary ID: 2009-015407-47
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: August 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Gastro-esophageal Junction Cancer
• Stomach Neoplasms

Intervention

Drug:
• AUY922
70mg/m2
• Docetaxel
Docetaxel 75mg/m2
• Irinotecan
Iriniotecan 350mg/m2

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Canada	Novartis Investigative Site	Montreal	Quebec
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Lyon Cedex
France	Novartis Investigative Site	Toulouse Cedex 9
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Ulm
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Roma	RM
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Netherlands	Novartis Investigative Site	Utrecht
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Singapore	Novartis Investigative Site	Singapore
Switzerland	Novartis Investigative Site	Bellinzona
Taiwan	Novartis Investigative Site	Kuei-Shan Chiang	Taoyuan/ Taiwan ROC
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Turkey	Novartis Investigative Site	Ankara
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Surrey	England
United Kingdom	Novartis Investigative Site	Sutton	Surrey
United States	The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU	Baltimore	Maryland
United States	Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology	Dallas	Texas
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)	Lake Success	New York
United States	University of California at Los Angeles Dept. of UCLA (4)	Los Angeles	California
United States	USC/Kenneth Norris Comprehensive Cancer Center USC/Norris	Los Angeles	California
United States	Tyler Cancer Center Dept.ofTylerCancerCtr. (2)	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Russian Federation,  Singapore,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary	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
Secondary	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
Secondary	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

External Links

•   ESMO Abstract
•   Results for CAUY922A2202 can be found on the Novartis Clinical Trial Results website