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Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.

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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

Result Received: No Study Results Posted

Website Link: https://ClinicalTrials.gov/show/NCT01439152

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