This randomized, dual-arm Phase II study will evaluate IMC-A12 as a single agent and in combination with Erbitux (cetuximab) in patients with metastatic head and neck cancer who have failed prior platinum-based treatment. Up to 90 patients are expected to be enrolled.
Based on supportive preclinical data indicating favorable anticancer interactions when IMC-A12 and Erbitux are combined, this Phase II study is designed to evaluate the efficacy, safety and pharmacology effects of IMC-A12 as a single agent and in combination with Erbitux. In addition to traditional Phase II endpoints, the effects of IMC-A12 and Erbitux on many potential cellular targets of IMC-A12 and Erbitux will be assessed by several academic institutions that hold National Cancer Institute (NCI) Special Programs of Research Excellence (SPORE) grants in head and neck cancer, which are among the wide variety of treatment centers participating in this trial.
Eric Rowinsky, chief medical officer and executive vice president of ImClone, said: “This study will evaluate whether the efficacy results observed with Erbitux in head and neck cancer patients with locally-advanced, recurrent and metastatic disease may be enhanced by combining IMC-A12.”