Jonasch E et al. - In a trial to evaluate the activity and safety of talactoferrin (TLF) in pts with refractory metastatic renal cell carcinoma (RCC), it was found that TLF is a well-tolerated new agent that has demonstrated preliminary signs of clinical activity Methods
44 adult pts with progressive advanced or metastatic RCC who had failed prior systemic therapy received oral talactoferrin at a dose of 1.5 g twice daily on a 12-week-on 2-week-off schedule
Pts were evaluated for progression-free survival (PFS) at 14 weeks, overall response rate, and PFS and overall survival (OS)
Results
TLF was well tolerated; no significant hematologic, hepatic, or renal toxicities were reported
The study met its predefined target with a 14-week PFS rate of 59%
The response rate was 4.5%; median PFS was 6.4 months and median OS was 21.1 months
