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This trial is testing the investigational drug IMC-1121B administered to Japanese patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available. The rationale for performing this trial is to establish the safety profile and the pharmacokinetics of IMC-1121B.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Advanced Solid Tumors
ImClone Investigational Site
Published on BioPortfolio: 2014-08-27T03:18:16-0400
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