Phase 1 Study of IMC-1121B in Patients With Advanced Solid Tumors
This single center, open-label, single-arm, Phase 1 study will enroll approximately 15 to 18
patients. The actual size will vary depending on the dose-limiting toxicities (DLTs)
observed and the resultant sizes of the cohorts. Patients will receive IMC-1121B,
administered intravenously, once every 2 or 3 weeks for 6 weeks (one cycle). After one
cycle of treatment, patients who have an objective response or stable disease may continue
to receive IMC-1121B at the same dose and schedule until disease progression or other
withdrawal criteria are met. A minimum of three patients will be enrolled in each cohort.
Dose escalation in successive cohorts will occur once all patients complete one cycle of
therapy.
Patients will be enrolled sequentially into each cohort.
A completed patient will be either a patient who completes the initial 6 week treatment
period (Cycle 1) or a patient who discontinues therapy for an IMC-1121B related toxicity
during Cycle 1. Patients who do not complete the first 6 weeks of treatment for reasons
other than an IMC-1121B -related toxicity will be replaced. Toxicity data for each cohort
will be reviewed prior to dose escalation. Upon completion of all required safety
evaluations during the initial 6 weeks, the next cohort of new patients will be treated at
the next higher dose level using a dose escalation scheme.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Adverse Events
Baseline to study completion
Yes
E-mail: ClinicalTrials@ ImClone.com
Study Director
ImClone LLC
Japan: Ministry of Health, Labor and Welfare
13898
NCT01005355
September 2009
February 2011
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