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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

Top West Virginia Mesothelioma Lawyer | Law Firm | Attorney | GPW > Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

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: 12

Gender: All

Min Age: 20 Years

Age Group: Adult, Older Adult

Current Status: Completed

Study Results: No Results Available

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

Interventions: BAY94-9343,

Phase:

Study Type: Interventional

Study Design: Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Treatment,

Primary Completion Date: April 28, 2017

Completion Date: July 4, 2017

Last  Posted Date: June 4, 2018

Location: National Cancer Center Hospital East, Kashiwa, Chiba, Japan

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

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