Enzastaurin for Patients With Metastatic Colorectal Cancer

Arms (1)

1. type

   EXPERIMENTAL

   label

   Enzastaurin HCl

   interventionNames

   1. Drug: Enzastaurin HCl

Primary outcomes (1)

1. measure

   Percentage of Participants With Progression Free Survival (PFS) at 6 Months

   timeFrame

   Baseline to 6 months

   description

   PFS defined as time from date of first dose of enzastaurin to first date of documented progressive disease (PD) or date of death (any cause), whichever occurred first. Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) PD defined as ≥20% increase in sum of the longest diameter (LD) of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of ≥1 new lesions. Participants not known to have died as of data-inclusion cut-off date and who did not have PD, PFS was censored at date of last progression-free disease assessment prior to date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at date of last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. PFS at 6 months = participants who were progression free and alive at 6 months divided by the number of treated participants x 100.