Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies
Condition Neoplasms Estimated Enrollment: 15 Age Group: 20 Years and older (Adult, Senior) Gender: All Study Type: Interventional Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment Study ID Numbers: 15404 Study First Received: June 26, 2015 Last Updated: March 16, 2017 Estimated Primary Completion Date: May 15, 2017 Primary Outcome Measures: Number of Treatment-emergent Adverse Events (TEAEs) as a measure of safety and tolerability|Intensity of TEAEs acc. to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.03|Cmax (maximum drug concentration in plasma after single dose administration ) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|Cmax,norm (Cmax divided by dose (mg) per kg body weight)...
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