Date: 2011-06-08
Type of information: Completion of the trial
phase: 1
Announcement: completion 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: metastatic pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: Spain, UK
Trial
details: This single-arm exploratory clinical trial will be performed in several centres and aims to test PM01183's antitumour activity as second-line treatment. The target population is adults with metastatic exocrine pancreatic cancer for which standard therapy has failed (i.e. the illness progressed during or after treatment with gemcitabine).
The trial includes patients who have relapsed within 6 months after suspending adjuvant therapy and whose illness had metastasised at the time they join the trial. At least 21 (first phase) and at most 43 evaluable patients will be treated in hospitals in Spain and the UK during this important trial.Zeltia has announced that subsidiary PharmaMar has concluded Phase I trials and commenced Phase II trials with PM01183 in metastatic pancreatic cancer.
The endpoint of the Phase II trial is Overall Survival at 6 months (OS6) in patients with metastatic pancreatic cancer.
Latest
news: Zeltia has announced that subsidiary PharmaMar has concluded Phase I trials and with PM01183 in metastatic pancreatic cancer. The proudct has attained the endpoint and PharmaMar has commenced a Phase II trial with the drug as second-line treatment.
