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

Phase 2

Completed

• Conditions: Advanced Gastric Cancer; Gastro-esophageal Junction Cancer
• Interventions: Drug: AUY922; Drug: Docetaxel; Drug: Irinotecan

• Registration Number: NCT01084330
• Lead Sponsor: Novartis Pharmaceuticals

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

Not available

Study Timeline

• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-10
• Study Start: 2010-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2020-08
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-26
• Disposition First Posted: 2020-09-02
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AUY922	AUY922	-
Docetaxel or Irinotecan	Docetaxel	-
Docetaxel or Irinotecan	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	21 day cycle: treatment until death, lost to follow up or withdrawal

Secondary Outcome Measures

Name	Time	Method
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.	21 day cycle: treatment until death, lost to follow up or withdrawal
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.	21 day cycle: treatment until death, lost to follow up or withdrawal
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922	21 day cycle: treatment until death, lost to follow up or withdrawal

Trial Locations

Locations (8)

University of California at Los Angeles Dept. of UCLA (4); 🇺🇸 Los Angeles, California, United States

Horizon Oncology Center; 🇺🇸 Lafayette, Indiana, United States

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology; 🇺🇸 Dallas, Texas, United States

USC/Kenneth Norris Comprehensive Cancer Center USC/Norris; 🇺🇸 Los Angeles, California, United States

Clinical Research Alliance Dept.ofArenaOncologyAssoc(2); 🇺🇸 Lake Success, New York, United States

The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU; 🇺🇸 Baltimore, Maryland, United States

Tyler Cancer Center Dept.ofTylerCancerCtr. (2); 🇺🇸 Tyler, Texas, United States

Novartis Investigative Site; 🇬🇧 Leicester, United Kingdom