This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Georgetn Univ Lombardi Can Ctr
Washington D.C., District of Columbia, United States
University Of Miami Miller School Of Medicine
Miami, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Safety assessment
Time frame: throughout the study
dose limiting toxicity (DLT)
Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximu tolerated dose is identified
Efficacy based on duration of response and time to progression based on assessment
Time frame: Measured every 8 weeks throughout the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution
Hamilton, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Amsterdam, Netherlands