E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic or locally advanced gastric cancer (stage IV) with HER2 overexpression |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017767 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to determine the response rate (CR + PR) according to RECIST criteria |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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: < 2.0 x upper normal limit (UNL) Creatinine < 1.5 x UNL AST and ALT < 2.5 x UNL; < 5 x UNL in patients with documented liver metastases Alkaline phosphatase: < 2.5 UNL Negative pregnancy test Willingness to give written informed consent, written consent for data protection and willingness to participate and comply with the study
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |