Date: 2017-02-20
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Hutchison China MediTech Limited "ChiMed" (China)
Product: savolitinib
Action
mechanism: c-Met inhibitor/tyrosine kinase inhibitor. Savolitinib is a selective and potential first-in-class oral c-Met inhibitor. Pulmonary sarcomatoid carcinoma is a rare subset of poorly differentiated non-small cell lung cancer. The sarcomatoid component of some of these tumors is believed to derive from carcinoma cells through the activation of Met. Met gene exon 14 skipping has been reported as one of the major genetic alterations in pulmonary sarcomatoid carcinoma, acting as a negative control in Met signaling. This genetic alteration has been found in approximately 20-30% of pulmonary sarcomatoid carcinoma patients. As such, a highly selective c-Met inhibitor may provide clinically meaningful benefit to patients with pulmonary sarcomatoid carcinoma.
Disease: pulmonary sarcomatoid carcinoma
Therapeutic area: Cancer - Oncology
Country: China
Trial
details: This phase II trial is an open-label, multicenter study of savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or unable to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory. (NCT02897479)
Latest
news: * On February 20, 2017, Hutchison China MediTech Limited (“Chi-Med”) announcesdthat a Phase II study of savolitinib has been initiated in locally advanced or metastatic pulmonary sarcomatoid carcinoma in China. The first drug dose was administered on February 10, 2017. This Phase II study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of savolitinib as a monotherapy in treating locally advanced or metastatic PSC patients harboring mesenchymal epithelial transition (“Met”) gene alterations. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS) and safety.
