Condition
Oncology
Estimated Enrollment: 147
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: 15051
Study First Received: September 1, 2011
Last Updated: February 16, 2017
Estimated Primary Completion Date: September 2017
Primary Outcome Measures:
Number of participants with treatment emergent adverse events|Determination of the Pharmakokinetic profile of BAY94-9343 and its metabolites|Biomarker evaluation: mesothelin plasma and Cytokeratin 18 (CK18) levels|Tumor response: assessment of best response, TTP (time to progression), and PFS (progression free survival) according to RECIST (Response Evaluation Criteria in Solid Tumours) 1.1|Immunogenicity assessment: assessment of anti BAY 94-9343 antibodies|Biomarker evaluation – Levels of mesothelin expression in tumor tissue
Sponsors and Collaborators:
Bayer
Website Link: https://ClinicalTrials.gov/show/NCT01439152
