PharmaMar initiates Phase I study of PM1183 to treat patients with solid tumours in Japan


PharmaMar has initiated its Phase I study of PM1183 (lurbinectedin) to treat patients with certain types of unresectable / advanced solid tumours in Japan.

PM1183 has been developed as an inhibitor of RNA polymerase II, an enzyme considered key for the transcription process that is over-activated in tumours with transcription addiction.

The Phase I study is being conducted as an open-label, multicentre study aimed at determining a recommended dose of PM1183 in Japanese patients.

" … The number of patients that are to be included will depend on the tolerability and activity observed in PM1183 and the dose level required to identify the recommended dose in this population."

The study's secondary goals are to assess the safety profile and antitumour activity along with determining the pharmacokinetic profile of PM1183 in Japanese patients when compared to Caucasians.

The study has considered patients either born in Japan or descendants from both Japanese parents that suffer disease progression according to the Response Criteria in Solid Tumours.

PharmaMar oncology business unit clinical development director Dr Arturo Soto said: “Three clinical sites in Japan will participate in the trial, the number of patients that are to be included will depend on the tolerability and activity observed in PM1183 and the dose level required to identify the recommended dose in this population.”

The anti-tumour efficacy of PM1183 is being investigated in several kinds of solid tumours, including the Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a key Phase III study for small-cell-lung cancer.