a clinical study comparing the efficacy and safety of AUY922, an investigational compound, to standard treatments in patients with advanced gastric cancer
Phase 1
- Conditions
- Patients with advanced gastric cancer who have progressed after one line of chemotherapyMedDRA version: 13.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-015407-47-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective:<br>to assess the treatment effect on progression-free survival (PFS) in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecan.<br>;Secondary Objective: Key secondary objectives:<br>- to estimate the overall survival treatment effect and other time-related endpoints. <br>- to estimate the objective response rate (ORR)<br>- to evaluate safety (based on CTCAE Version 3.0) and tolerability, and to characterize the pharmacokinetics (PK) of AUY922 patients in both Asian and Caucasian populations where feasible. ;Primary end point(s): Primary Endpoint<br>Progression-free survival (PFS) <br>;Timepoint(s) of evaluation of this end point: at baseline and every 6 weeks (±1 week) after start of study treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Endpoints include <br> - Efficacy: Overall survival (OS), and Objective response rate (ORR) Response assessments per RECIST<br>- Safety: Incidence of adverse drug reactions and serious adverse drug reactions as assessed by CTCAE Version 3.0<br>- PK: Exposure of AUY922 and parameters: e.g. Cmax, and Ctrough (AUC and T1/2 in PK subpopulation)<br>- other protocol defined secondary end points