Condition
Cancer
Estimated Enrollment: 15
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: BP29387|2014-002935-32
Study First Received: December 11, 2014
Last Updated: July 22, 2016
Estimated Primary Completion Date: August 2015
Primary Outcome Measures:
Safety: incidence of dose-limiting toxicities, adverse events, laboratory abnormalities; incidence of anti-drug antibodies, abnormal findings on physical examination, infusion-related reactions (composite outcome measure)|Pharmacokinetic profile of RO6927005 monotherapy based on free and total plasma RO6927005 concentrations over time (area under the curve)|Pharmacokinetic profile of RO6927005 in combination with gemcitabine/nab-paclitaxel, based on free and total plasma RO6927005 concentrations over time (area under the curve)|Efficacy: objective response rate, disease control rate, duration of response, progression-free survival, overall survival (composite outcome measure)
Sponsors and Collaborators:
Hoffmann-La Roche
Website Link: https://ClinicalTrials.gov/show/NCT02317419
