A Phase II Trial of Salirasib in Patients with Lung Adenocarcinomas with KRAS Mutations

摘要: Introduction KRAS mutations are present in 30% of lung adenocarcinomas. Salirasib prevents Ras membrane binding thereby blocking the function all isoforms. This phase II study determined activity salirasib patients with advanced adenocarcinomas mutations. Methods Two cohorts stage IIIB/IV adenocarcinoma were eligible: tumors who previously treated chemotherapy and receiving initial therapy had ≥15 pack-year smoking history. was given orally from days 1 to 28 a 35-day cycle. The primary end point rate nonprogression at 10 weeks. Results Thirty-three enrolled. Thirty (23 7/10 no prior therapy). Of patients, 7 23 (30%) stable disease weeks, 4 (40%) untreated No patient radiographic partial response (0% observed rate, 95% confidence interval 0–12%). median overall survival not reached (>9 months) for it 15 months received chemotherapy. Diarrhea, nausea, fatigue most common toxicities. Conclusions current dose schedule has insufficient treatment mutant warrant further evaluation. successful enrollment 30 over single site demonstrates that drug trials directed -specific genotype cancer feasible.