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) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|Cmax/D (Cmax divided by dose (mg)) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|AUC(0-tlast) (area under the plasma concentration vs time curve from time 0 to the last data point) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|AUC(0-tlast)norm (AUC(0-tlast) divided by dose (mg) per kg body weight) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|AUC(0-tlast)/D (AUC(0-tlast) divided by dose (mg)) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|tmax (time to reach maximum drug concentration in plasma) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me|Tumor response based on RECIST (Response Evaluation Criteria in Solid Tumors)|Level of mesothelin expression using IHC (Immunohistochemistry) staining for the tumor tissue obtained from fresh or archival tumor tissue|Plasma levels of soluble mesothelin|Immunogenicity evaluation based on anti-BAY94-9343 antibody count
Sponsors and Collaborators:
Bayer
Website Link: https://ClinicalTrials.gov/show/NCT02485119
