Date: 2017-02-17
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: National Cancer Institute (NCI) BERG (USA - MA)
Product: BPM 31510-IV (ubidecarenone)
Action mechanism:
Disease: gliosarcoma, recurrent glioblastoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase I trial studies the side effects and best dose of ubidecarenone injectable nanosuspension (BPM31510) in treating patients with glioblastoma or gliosarcoma that has come back and have been previously treated with bevacizumab. BPM31510 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. (NCT03020602)
Latest
news: * On February 15, 2017, Berg announced that it has initiated a Phase I/II monotherapy clinical trial for its drug candidate BPM 31510-IV for the potential treatment of glioblastoma multiforme. The compound was guided in development by BERG's unique AI-based Interrogative Biology® platform that combines patient biology and artificial intelligence-based analytics to better understand the differences between healthy and disease environments. The Phase I/II open-label, non-randomized clinical trial is designed to evaluate the safety and tolerability of BPM 31510-IV in subjects with glioblastoma multiforme that has recurred on a bevacizumab-containing regimen. Secondary outcome measures are to characterize the pharmacokinetics and pharmacodynamics of BPM31510-IV in subjects with glioblastoma multiforme that has recurred on a bevacizumab-containing regimen. The trial is initially being conducted at the Stanford University School of Medicine by principal investigators Dr. Seema Nagpal and Dr. Lawrence Recht.
