drugset / Trial / NCT00520481
Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cixutumumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Cixutumumab | Monoclonal antibody | 20 mg/kg | Intravenous |