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This study (LOGiC) compares adding Lapatinib to chemotherapy versus placebo in patients with HER2 (ErbB2)-positive, unresectable advanced or metastatic gastric cancer. It included patients with confirmed HER2 amplification. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key inclusion criteria: * Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction. * Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease. * Measurable or non-measurable, but radiologically evaluable disease, according to RECIST. * HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible. * 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. Key exclusion criteria: * 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.