A global and multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with chemotherapy (cisplatin/capecitabine), as therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
- Conditions
- Metastatic HER2-positive adenocarcinoma of the stomach or gastro-esophageal junction.MedDRA version: 16.0Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: 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
- EUCTR2011-001526-19-CZ
- Lead Sponsor
- F.Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 406
1. Male or female. Age = 18 years.
4. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least lung or liver or both
5. Measurable disease according to RECIST 1.1. or non-measurable evaluable disease
6. At least 2 organs involved by metastatic gastric tumor (including at least lung or liver or both) in addition to the site of the primary tumor. Metastasis in distant lymph nodes, peritoneal metastasis, malignant pleural effusion, etc. count as ‘organs’ in this
context.
7. HER2 positive (defined as either IHC3+ or IHC2+/ISH+, with ISH positivity defined as a ratio of >=2.0 of HER2 gene copy number/number of signals for CEP 17) primary or metastatic tumor, as assessed by central laboratory
8. CCR >=45 ml/min
9. ECOG PS = 2
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 263
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 142
1. Previous chemotherapy for locally advanced or metastatic disease
2. Prior gastrectomy
3. Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
4. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g., patients with a jejunostomy probe, gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine, as capecitabine is an orally administered drug.
6. Residual relevant toxicity resulting from previous therapy
11. History of documented congestive heart failure; angina pectoris requiring medication; electrocardiogram (ECG) evidence of trans-mural myocardial infarction; poorly controlled hypertension (systolic blood pressure (BP) > 180 mmHg or diastolic BP>100 mm Hg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias
12. Baseline LVEF< 50%, documented by echocardiography, MUGA scan, or cardiac MRI.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method