NCT01871311

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Nilotinib + Cetuximab	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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-06-06
• Last updated: 2019-02-08

Locations

1 site across 1 country: United States