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Completed

NCT Number: NCT01084330

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

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.

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Key information

Conditions

Advanced Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastro-esophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUY922

Drug

70mg/m2

docetaxel

Drug

Docetaxel 75mg/m2

Irinotecan

Drug

Iriniotecan 350mg/m2

Primary outcomes

  1. Progression Free Survival

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 10, 2010
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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