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

Tracking Information

First Received Date ^ICMJE

March 5, 2010

Last Updated Date

April 21, 2011

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01084330 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 comparatoe 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 comparatoe 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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Type ^ICMJE

Interventional

Study Phase

Phase II

Study Design ^ICMJE

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

Condition ^ICMJE

Advanced Gastric Cancer
Gastro-esophageal Junction Cancer

Intervention ^ICMJE

Drug: AUY922
70mg/m2
Drug: Docetaxel or Irinotecan
Docetaxel 75mg/m2 Irinotecan 350mg/m2

Study Arms

Experimental: AUY922
Intervention: Drug: AUY922
Active Comparator: Docetaxel or Irinotecan
Intervention: Drug: Docetaxel or Irinotecan

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

120

Completion Date

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, France, Germany, Italy, Korea, Republic of, Lebanon, Netherlands, Russian Federation, Singapore, Switzerland, Taiwan, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01084330

Other Study ID Numbers ^ICMJE

CAUY922A2202, Eudra CT 2009-015407-47

Has Data Monitoring Committee

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP