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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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