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

Primary Purpose

Advanced Gastric Cancer, Gastro-esophageal Junction Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AUY922
Docetaxel
Irinotecan
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring gastric cancer, metastatic gastric cancer, advanced gastric cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Kenneth Norris Comprehensive Cancer Center USC/Norris
  • University of California at Los Angeles Dept. of UCLA (4)
  • Horizon Oncology Center
  • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
  • Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
  • Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
  • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AUY922

Docetaxel or Irinotecan

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

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.
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922

Full Information

First Posted
March 5, 2010
Last Updated
December 8, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01084330
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer, Gastro-esophageal Junction Cancer
Keywords
gastric cancer, metastatic gastric cancer, advanced gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AUY922
Arm Type
Experimental
Arm Title
Docetaxel or Irinotecan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AUY922
Intervention Description
70mg/m2
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75mg/m2
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Iriniotecan 350mg/m2
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary Outcome Measure Information:
Title
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.
Time Frame
21 day cycle: treatment until death, lost to follow up or withdrawal
Title
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Time Frame
21 day cycle: treatment until death, lost to follow up or withdrawal
Title
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922
Time Frame
21 day cycle: treatment until death, lost to follow up or withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
USC/Kenneth Norris Comprehensive Cancer Center USC/Norris
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California at Los Angeles Dept. of UCLA (4)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Horizon Oncology Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0013
Country
United States
Facility Name
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56100
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Novartis Investigative Site
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Kuei-Shan Chiang
State/Province
Taoyuan/ Taiwan ROC
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Novartis Investigative Site
City
Surrey
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leicester
ZIP/Postal Code
LE7 5WW
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.embase.com/search/results?subaction=viewrecord&rid=3&page=1&id=L71716851
Description
ESMO Abstract
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8643
Description
Results for CAUY922A2202 can be found on the Novartis Clinical Trial Results website

Learn more about this trial

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

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