Date: 2013-05-20
Type of information: Initiation of preclinical development
phase: 1b
Announcement: initiation of the study
Company: PharmaMar (Spain)
Product: PM01183 (lurbinectidin) in combination with capecitabine
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: advanced solid tumors
Therapeutic area: Cancer - Oncology
Country: Belgium, Spain
Trial details:
Latest
news: * On May 20, 2013, Zeltia has announced that its subsidiary PharmaMar has commenced a Phase Ib trial with PM01183 in combination with capecitabine. It is a prospective open escalating dose Phase I trial with PM01183 and capecitabine in patients with unresectable metastatic breast cancer, pancreatic cancer, and metastatic colon cancer.
The primary endpoint of the trial is to determine the recommended dose (RD) for PM01183 in combination with Capecitabine in patients with advanced solid tumors. Secondary endpoints include obtaining information about the combination\'s safety profile and the pharmacokinetic characteristics of both drugs when administered together, performing a pharmacogenomic analysis and exploring activity in the tumors selected for the trial. The trial will be performed in two hospitals: in Spain (Vall d’Hebron Hospital, Barcelona) and in Belgium (Institut Jules Bordet, Brussels).
