drugset / Trial / NCT00778817

IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery

NCT00778817

Phase 2 Terminated 20 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This randomized phase II trial is studying mitotane and IMC-A12 to see how well they work compared with mitotane alone in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as mitotane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether mitotane is more effective with or without monoclonal antibody IMC-A12 in treating adrenocortical cancer.

Timeline

Start
2008-12
Primary completion
2012-05
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cixutumumab Monoclonal antibody Intravenous
Subject Mitotane Small molecule Oral