Phase 1 Study of the Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available
This multicenter study will enroll approximately 40 subjects. The actual sample size will
vary depending on how many subjects are needed to obtain at least 3 complete subjects per
cohort.
IMC-3C5 will initially be administered once every week (Cohorts 1-4) in a dose escalated
manner. The starting dose will be 5mg/kg weekly (Cohort 1). Dose escalation will proceed to
10mg/kg (Cohort 2), 20 mg/kg (Cohort 3), and 30mg/kg (Cohort 4). Based on an analysis of the
safety and pharmacokinetic profile of weekly dosing, subjects may be enrolled sequentially
into 2 every-other-week dose cohorts (Cohorts 5-6, 20mg/kg and 30mg/kg). Intermediate doses
may also be used.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Adverse Events
Approximately 36 Months
Yes
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
ImClone LLC
United States: Food and Drug Administration
14247
NCT01288989
March 2011
December 2015
Name | Location |
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Manhassaet, New York |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis, Indiana 46227 |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Springfield, Massachusetts |