Disease | Colorectal cancer |
Stage of Disease/Treatment | Metastatic/advanced |
Prior Therapy | More than two prior regimens |
Type of Study | Phase II, single arm |
Primary Endpoint | Progression‐free survival |
Secondary Endpoints |
Overall survival Overall response rate Toxicity PFS rate at 3 months OS rate at 3 months Clinical benefit rate |
Additional Details of Endpoints or Study Design | |
The primary endpoint of the study was PFS defined as the time from the treatment to disease progression or death from any cause, whichever came first. Patients who did not progress or were lost to follow‐up were censored at the day of their last objective tumor assessment. OS was defined as the time from the date of treatment start to the date of death from any cause. If the patient was alive at the end of the follow‐up period or was lost to follow‐up, OS was censored on the last date the patient was known to be alive. SD was defined by RECIST version 1.1 measurements as a component of best overall response. It was calculated from the start of treatment time until the criteria for progression were met, taking as reference the smallest measurements recorded since the treatment started. Upon treatment discontinuation, subjects were contacted every 8 weeks to assess survival status. | |
Investigator's Analysis | Active and should be pursued further |