LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Exclusion Criteria

• •Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization.
• •Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO).
• •Prior/Concurrent Therapy:
• •* At least 3 weeks following major surgery, such as gastrectomy, and were recovered from any related toxicity More than 5 years since prior chemotherapy for malignancy other than GC. At least 4 weeks since prior radiotherapy
• •* More than 5 years since prior biologic or hormonal therapy or immunotherapy for malignancy other than gastric carcinoma.
• •Pregnant or lactating females at any time during the study.
• •Known history of active CNS disease.
• •Uncontrolled ascites.
• •Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.
• •Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
• •Prior palliative chemotherapy for the treatment of gastric cancer.
• •Prior treatment with oxaliplatin-based neoadjuvant or adjuvant chemotherapy completed \<12 months.
• •Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn's disease or ulcerative colitis).
• •Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
• •Uncontrolled infection.
• •History of other malignancy. However, subjects who were disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, were eligible.