Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Cetuximab

Nilotinib

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All patients with receive Nilotinib BID for a 28-day cycle + Cetuximab 400 mg/m2 on day 1 dose then 250 mg/m2 weekly

Nilotinib BID for a 28-day cycle + Cetuximab 400 mg/m2 on day 1 dose then 250 mg/m2 weekly

Three dose levels for nilotinib:

Dose level -1 200-mg daily Dose level 1 200-mg BID Dose level 2 300-mg BID

Cycle duration will be 4 weeks, with weekly evaluation of toxicity. Assessment of tumor progression will occur every 2 cycles. Subjects will be treated until disease progression or cessation due to intolerable toxicity.

Nilotinib + Cetuximab

Ann W Gramza, MD

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.

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.

A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors

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

The dose at which \</= 1 out of 6 subjects experiences a dose limiting toxicity

Novartis

Georgetown University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors	NCT01871311	Colorectal Canc... Head and Neck C...	Nilotinib + Cet...	18 Years -	Georgetown University
A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors	NCT01871311	Colorectal Canc... Head and Neck C...	Nilotinib + Cet...	18 Years -	Georgetown University

Spots Global Cancer Trial Database for nilotinib + cetuximab