drugset / Trial / NCT00520481

Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer

NCT00520481

Phase 2 Completed 41 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

Summary

This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment.

Timeline

Start
2007-08
Primary completion
2012-01
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cixutumumab Monoclonal antibody 10 mg/kg Intravenous
Subject Cixutumumab Monoclonal antibody 20 mg/kg Intravenous