Metastatic or locally advanced gastric cancer (stage IV) with HER2 overexpression MedDRA version: 7.1 Level: PT Classification code 10017767
Conditions
Sponsors
Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years (ethnical group: any; gender: female and male) Progression under or after one prior platinum-based or 5-fluoropyrimidine-based chemotherapy in metastatic disease At least four weeks from the last platinum-based or 5-fluoropyrimidin-based chemotherapy Histological proof of gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction with HER2 overexpression of the primary or metastatic tumor tissue determined by immunohistochemistry and FISH (Score IHC 3+ or Score IHC 2+ and FISH +) Metastatic (M1) or locally advanced disease At least one measurable lesion evaluable for response (RECIST criteria) Estimated life expectancy of > 3 months ECOG Performance Status: 0-2 Adequate cardiac function: LVEF > 50% (detected by echocardiogram) Absolute neutrophil count > 1,500/µl Absolute platelet count > 100,000 /µl Serum total bilirubin: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age > 75 years Concurrent therapy with any other chemo-/immunotherapeutical regime Clinically significant cardiac disease (cardiac insufficiency, NYHA III/IV, uncontrolled arrhythmia or hypertension, symptomatic angina pectoris, clinically significant valvular heart disease, history of congestive heart failure) LVEF < 50% Pregnant or lactating women Patients (M/F) with reproductive potential not implementing adequate contraceptive measures Known hypersensitivity reactions to the compounds Patients with active or uncontrolled infections/concurrent illness Patients with advanced pulmonary disease, severe dyspnoe or requiring oxygen therapy Patients with brain or meningeal metastases. Radiologic studies are not required to rule this out unless there is clinical suspicion of CNS disease Other co-exisiting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of cervical cancer in situ. Patients curatively treated and free of disease for at least 5 years will be discussed with the sponsor before inclusion. Concomitant or within a 4-week period administration of any other experimental drug under investigation. Alcohol and/or drug abuse Patients who cannot be regularly observed for psychological, sociological, geographical reasons or other concomitant conditions not permitting adequate follow-up and compliance of the protocol patient was already recruited in this trial before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine the response rate (CR + PR) according to RECIST criteria;Secondary Objective: to determine clinical benefit rate (CR + PR + SD) according to RECIST criteria - to determine Time to Progression - to determine Duration of Response - to determine survival - to evaluate the safety of trastuzumab monotherapy in patients with metastatic or locally advanced gastric cancer ;Primary end point(s): response rate | — |
Countries
Austria
Outcome results
None listed