Date: 2016-11-28
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: PharmaMar (Spain)
Product: PM01183 (lurbinectidin)
Action
mechanism: transcriptional inhibitor. PM01183 is a novel synthetic marine-derived compound that covalently binds to the minor groove of the DNA. These PM01183-DNA adducts give rise to double strand breaks and perturbations of the cell cycle inducing cell death. PM01183 induces a specific degradation in tumour cells of RNA polymerase II, without interfering other RNA polymerases (I and III)-the degradation depends on whether the transcription process is active (transactivated transcription) and does not affect basal transcription. In preclinical trials, the compound evidenced strong activity against tumour cell lines of different origins.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: Japan
Trial details:
Latest
news: * On November 28th, 2016, PharmaMar has announced the start of an open-label, multicenter, Phase I study in Japan to evaluate the recommended dose (RD) of PM1183 (lurbinectedin) in patients with certain types of
unresectable/advanced solid tumors. The main objective of the study is to determine the recommended dose of PM1183 in Japanese patients. Furthermore, the secondary objective will be to evaluate the safety profile, to obtain preliminary information on the antitumor activity along with pharmacokinetic characteristics of PM1183 in Japanese patients when compared to Caucasians.
The study population has to be patients born in Japan or descendants from both Japanese parents that suffer disease progression according to the Response Criteria in Solid Tumors (RECIST v1.1). 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.
