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

December 8, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, 33075
        • Novartis Investigative Site
      • Lyon Cedex, France, 69373
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Novartis Investigative Site
  • Germany
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80131
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41100
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Novartis Investigative Site
  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
        • Novartis Investigative Site
      • Suwon, Gyeonggi-do, Korea, Republic of, 443-380
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
  • Netherlands
      • Utrecht, Netherlands, 3584CX
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Novartis Investigative Site
      • Moscow, Russian Federation, 129128
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Novartis Investigative Site
  • Taiwan
      • Tainan, Taiwan, 704
        • Novartis Investigative Site
      • Taipei, Taiwan, 10048
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
    • Taoyuan/ Taiwan ROC
      • Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan, 33305
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06500
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE7 5WW
        • Novartis Investigative Site
    • England
      • Surrey, England, United Kingdom, GU2 7XX
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Novartis Investigative Site
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Kenneth Norris Comprehensive Cancer Center USC/Norris
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles Dept. of UCLA (4)
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
    • Maryland
      • Baltimore, Maryland, United States, 21287-0013
        • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
    • New York
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AUY922
Drug: AUY922
70mg/m2
ACTIVE_COMPARATOR: Docetaxel or Irinotecan
Drug: Docetaxel
Docetaxel 75mg/m2
Drug: Irinotecan
Iriniotecan 350mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
21 day cycle: treatment until death, lost to follow up or withdrawal

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
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
Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
21 day cycle: treatment until death, lost to follow up or withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (ESTIMATE)

March 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2020

Last Update Submitted That Met QC Criteria

December 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUY922A2202
  • 2009-015407-47 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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