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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
Bu çalışma (LOGiC), HER2 (ErbB2) pozitif, ameliyatla alınamayan ileri veya metastatik mide kanseri (gastric cancer) hastalarında kemoterapiye Lapatinib eklemenin etkisini plaseboyla karşılaştırıyor. HER2 amplifikasyonu doğrulanmış hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.