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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01084330
First received: March 5, 2010
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Gastric Cancer
Gastro-esophageal Junction Cancer
 Drug: AUY922
Drug: Docetaxel
Drug: Irinotecan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal ] [ Designated as safety issue: No ]

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. [ Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AUY922 Drug: AUY922
70mg/m2
Active Comparator: Docetaxel or Irinotecan Drug: Docetaxel
Docetaxel 75mg/m2
Drug: Irinotecan
Docetaxel or Iriniotecan
Other Name: Iriniotecan 350mg/m2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084330

  Show 37 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01084330     History of Changes
Other Study ID Numbers: CAUY922A2202, 2009-015407-47
Study First Received: March 5, 2010
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration
Singapore: Health Sciences Authority
Germany: Federal Institute for Drugs and Medicinal Products
Canada: Health Canada
France: Health Authority

Keywords provided by Novartis:
gastric cancer
metastatic gastric cancer
advanced gastric cancer

Additional relevant MeSH terms:
Esophageal Diseases
Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Stomach Diseases
Irinotecan
Docetaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013