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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Gastric Cancer, Gastro-esophageal Junction Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

21 day cycle: treatment until death, lost to follow up or withdrawal

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAUY922A2202

NCT ID:

NCT01084330

Start Date:

April 2010

Completion Date:

May 2012

Related Keywords:

  • Advanced Gastric Cancer
  • Gastro-esophageal Junction Cancer
  • gastric cancer
  • metastatic gastric cancer
  • advanced gastric cancer
  • Esophageal Diseases
  • Stomach Neoplasms

Name

Location

Horizon Oncology CenterLafayette, Indiana  47905
Arena Oncology Associates, PC Dept.ofArenaOncologyAssoc(2)Lake Success, New York  11042
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)Tyler, Texas  75702
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHUBaltimore, Maryland  21231
UCLA/ University of California Los Angeles Dept. of UCLA (4)Los Angeles, California  90095
USC/Kenneth Norris Comprehensive Cancer Center USC/NorrisLos Angeles, California  90033
University of California at Los Angeles Dept. of UCLA (4)Los Angeles, California  90095
Baylor College of Medicine Baylor Texas OncologyDallas, Texas  75246