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

NCT ID: NCT01084330

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Gastric Cancer Gastro-esophageal Junction Cancer

Keywords

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gastric cancer metastatic gastric cancer advanced gastric cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AUY922

Group Type EXPERIMENTAL

AUY922

Intervention Type DRUG

70mg/m2

Docetaxel or Irinotecan

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Docetaxel 75mg/m2

Irinotecan

Intervention Type DRUG

Iriniotecan 350mg/m2

Interventions

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AUY922

70mg/m2

Intervention Type DRUG

Docetaxel

Docetaxel 75mg/m2

Intervention Type DRUG

Irinotecan

Iriniotecan 350mg/m2

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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USC/Kenneth Norris Comprehensive Cancer Center USC/Norris

Los Angeles, California, United States

Site Status

University of California at Los Angeles Dept. of UCLA (4)

Los Angeles, California, United States

Site Status

Horizon Oncology Center

Lafayette, Indiana, United States

Site Status

The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU

Baltimore, Maryland, United States

Site Status

Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

Lake Success, New York, United States

Site Status

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

Dallas, Texas, United States

Site Status

Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

Tyler, Texas, United States

Site Status

Novartis Investigative Site

Adelaide, South Australia, Australia

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Ulm, , Germany

Site Status

Novartis Investigative Site

Genova, GE, Italy

Site Status

Novartis Investigative Site

Modena, MO, Italy

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Napoli, , Italy

Site Status

Novartis Investigative Site

Utrecht, , Netherlands

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Bellinzona, , Switzerland

Site Status

Novartis Investigative Site

Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan

Site Status

Novartis Investigative Site

Tainan City, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Surrey, England, United Kingdom

Site Status

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Site Status

Novartis Investigative Site

Glasgow, , United Kingdom

Site Status

Novartis Investigative Site

Leicester, , United Kingdom

Site Status

Countries

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Lebanon United States Australia Canada France Germany Italy Netherlands Russia Singapore South Korea Switzerland Taiwan Turkey (Türkiye) United Kingdom

Related Links

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Other Identifiers

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2009-015407-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAUY922A2202

Identifier Type: -

Identifier Source: org_study_id