4 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
The primary objective of this study is to determine whether the Impella cVAD device vs. IABP therapy leads to a higher 30 day survival rate in shock STEMI patients in the setting of primary PCI.
The present study aims to:A) acquire a pharmacokinetic model of [18F]PSMA ([18F]-DCFPyl), by which simplified methods to quantify [18F]PSMA PET signal will be validated ; andB) assess the repeatability of those simplified quantitative method.
Primary ObjectivesThe primary objectives of this study are:Phase I, Part A - Dose Escalation:• To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CB-103 as a single agent when administered orally and with repeat…