Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

3525 Background: Figitumumab (F; CP-751,871) is a fully human monoclonal antibody (mAb) that inhibits IGF-IR. This phase II trial examined the efficacy and safety of F in patients (pts) with refractory mCRC. METHODS: Pts (male or female) had an ECOG PS of 0 or 1, and had received prior chemotherapy (+/- mAb therapy). Cohort A received intravenous (iv) F 20 mg/kg q3w. Following a protocol amendment a further cohort received iv F 30 mg/kg q3w (Cohort B). F was dosed on days 1 and 2 of cycle 1 (loading dose) and on day 1 of each subsequent cycle. The primary endpoint was 6-month overall survival (6-mo OS). HYPOTHESIS: H0 p=.45 (p=probability of 6-mo OS) vs. H1 p>.45. Secondary endpoints included safety, PFS, OS, and PK. Associations between plasma levels of free-IGF-1 (fIGF-1) and OS were examined. RESULTS: 168 pts (Cohort A n=85; Cohort B n=83) were treated. Pts were heavily pretreated: 76% (Cohort A) and 77% (Cohort B) had received ≥3 prior systemic regimes. The probability of 6-mo OS was not significantly greater than .45 for either cohort (Table). There was a trend toward longer median OS in pts with high levels of fIGF-1 (Table). The most common grade 3/4 non-hematologic AEs in Cohort A were hyperglycemia (16%), asthenia (13%), and fatigue (6%), and in Cohort B hyperglycemia (22%) and asthenia (13%). The most common hematologic abnormalities in both cohorts were lymphopenia (Cohort A 6%; Cohort B 4%) and anemia (Cohort A 5%; Cohort B 3%). Overall, F 20 mg/kg was better tolerated than F 30 mg/kg. Plasma concentrations of F suggest that a loading dose of F facilitated early achievement of steady state concentrations in Cycle 1. CONCLUSIONS: 6-mo OS results do not support further study of F 20 or 30 mg/kg in pts with refractory mCRC. In both cohorts there was a trend toward longer median OS in pts with high levels of fIGF-1. [Table: see text].


Journal article


J Clin Oncol

Publication Date