PharmaMar begins phase II 'Basket' trial to evaluate safety, efficacy of PM1183 in advanced solid tumors

Sep 18 2015

PharmaMar announced today the start of a multicenter, international, open-label, exploratory phase II "Basket" trial (NCT02454972) to evaluate the efficacy and safety of the anticancer agent PM1183 (lurbinectedin) in advanced solid tumors. This "Basket" trial will include patients that have different solid cancers in advanced stages, including small cell lung cancer (SCLC), head and neck cancer, neuroendocrine tumors (NETs), biliary tract tumors, endometrial cancer, BRCA 1/2-associated breast cancer, germ cell tumors and Ewing's family of tumors as well as other tumors of unknown primary site.

The transcription inhibitor PM1183 will be tested in up to 225 cancer patients in the US and Europe. The primary endpoint will assess the overall response rate (ORR), which is the proportion of patients that have either a complete or partial response, obtained with PM1183 in each of these tumors. The secondary objectives of the study will include endpoints to better characterize the activity of PM1183, such as duration of response, clinical benefit, progression-free survival (PFS) and overall survival at one year. In addition, this study will evaluate the safety and pharmacological profile of PM1183 in these patients, as well as pharmacogenetic and pharmacogenomics analyses to explore individual variability and predictive factors of drug response, respectively.

"This basket trial will help us identify in which advanced cancers with limited or no treatment options, PM1183 will be more effective and will provide valuable data for the therapeutic development of this drug in different tumors," said Dr. Arturo Soto, Clinical Development Director, PharmaMar.

Source: Pharmamar