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.

Phase 1

• Conditions: Metastatic HER2-positive adenocarcinoma of the stomach or gastro-esophageal junction.; MedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001526-19-PT
• Lead Sponsor: F.Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-27
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

1. Male or female. Age = 18 years.

2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least two organs (at least lung or liver or both)

3. Measurable disease according to RECIST 1.1.

4. 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

5. CCR >=45 ml/min

6. 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

Exclusion Criteria

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. Residual relevant toxicity resulting from previous therapy

5. 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

6. 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