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

PHASE1TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Colorectal CancerHead and Neck Cancer
Interventions
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."

Trial Locations (1)

20007

Georgetown Lombardi Comprehensive Cancer Center, Washington D.C.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Georgetown University

OTHER