Date: 2016-05-17
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: BI 695502 (biosimilar version of bevacizumab - Avastin®)
Action
mechanism: monoclonal antibody/biosimilar. Bevacizumab is a humanized antibody to vascular endothelial growth factor (VEGF). It binds VEGF and prevents the interaction of VEGF to its receptors on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation.
Disease: colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Chile, Japan, Spain, Ukraine, USA
Trial
details: The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response [CR] plus partial response [PR]), overall survival (OS), duration of response (DOR), time to progression (TTP). (NCT02776683)
Latest
news: * On May 17, 2016, a Phase 3 trial sponsored by Boehringer Ingelheim was published on the NIH website ClinicalTrials.gov for BI 695502 and is currently recruiting participants.
