Spots Global Cancer Trial Database for A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors
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Trial Identification
Brief Title: A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors
Official Title: A Phase I Study of the BCR-ABL Tyrosine Kinase Inhibitor Nilontinib and Cetuximab in Patients With Solid Tumors That Can be Treated With Cetuximab
Study ID: NCT01871311
Interventions
Study Description
Brief Summary: The purpose of this study is to determine the recommended Phase II dose of nilotinib when used in combination with cetuximab in the treatment of patients with recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.
Detailed Description: ABL1 has been suggested to play a key role in the resistance mechanism to anti EGFR therapy in cancer. Therefore, this study aims to evaluate the safety and possible effect of targeting both EGFR using cetuximab along with ABL1 using nilotinib. Correlative studies assess the changes in tumor proteome in response to therapy and magnitude of ADCC as a marker of antibody activity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Contact Details
Name: Ann W Gramza, MD
Affiliation: Georgetown University
Role: PRINCIPAL_INVESTIGATOR
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