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Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

Estimated reading time: 1 min

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

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT02485119

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