BACKGROUND: Intetumumab is a fully human mAb with antiangiogenic, antitumor 
properties which has shown potential therapeutic effect in castration-resistant 
prostate cancer (CRPC) patients.
PATIENTS AND METHODS: In a phase 2, randomized, double-blind, multicenter study, 
men with metastatic CRPC without prior systemic nonhormonal therapy were 
randomly assigned to 75-mg/m(2) docetaxel (Taxotere) and 5-mg prednisone plus 
placebo (N = 65) or 10-mg/kg intetumumab (N = 66) q3w. Placebo patients with 
progressive disease (PD) could cross over to 10-mg/kg intetumumab alone or with 
docetaxel. The primary end-point was progression-free survival (PFS). The 
secondary end-points included tumor response (complete response + partial 
response, CR + PR), prostate-specific antigen (PSA) response, and overall 
survival (OS).
RESULTS: All efficacy end-points favored placebo over intetumumab, including PFS 
(median 11.0 versus 7.6 months, P = 0.014), tumor response (20% versus 16%, P = 
0.795), PSA response (68% versus 47%, P = 0.018), OS (median 20.6 versus 17.2 
months, P = 0.163). Common all-grade adverse events (AEs) with placebo and 
intetumumab were alopecia (43% versus 26%); diarrhea, leukopenia (both 34% 
versus 27%); neutropenia (35% versus 23%). Grade ≥ 3 leukopenia (28% versus 17%) 
and neutropenia (26% versus 18%) occurred more often with placebo than with 
intetumumab. Intetumumab serum concentrations increased with repeated dosing and 
did not reach steady-state. Greater decreases in N-telopeptide of type I 
collagen (NTx), C-telopeptide (CTx) and CTCs occurred with intetumumab than with 
placebo.
CONCLUSION: The addition of intetumumab to docetaxel resulted in shorter PFS 
without additional toxicity among CRPC patients.