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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Gastric Cancer, Gastro-esophageal Junction Cancer

Intervention / Treatment
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* Drug: AUY922
* Drug: Docetaxel
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUY922<br> | Drug: AUY922<br>* 70mg/m2<br>|
| Active Comparator: Docetaxel or Irinotecan<br> | Drug: Docetaxel<br>* Docetaxel 75mg/m2<br>Drug: Irinotecan<br>* Iriniotecan 350mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 21 day cycle: treatment until death, lost to follow up or withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, metastatic gastric cancer, advanced gastric cancer