A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and USlicensed Avastin®.

Summary

Participation Requirements

Description

The primary PK parameter endpoints are Cmax and AUC0-? for bevacizumab. The secondary PK endpoints will include all other PK parameters for bevacizumab, including tmax, t1/2, CL and AUC(0-t). The serum PK parameters of bevacizumab will be calculated using standard noncompartmental methods. An analys...

The primary PK parameter endpoints are Cmax and AUC0-? for bevacizumab. The secondary PK endpoints will include all other PK parameters for bevacizumab, including tmax, t1/2, CL and AUC(0-t). The serum PK parameters of bevacizumab will be calculated using standard noncompartmental methods. An analysis of covariance model will be used to analyse the log-transformed primary PK parameters (AUC[0 ?] and Cmax) and AUC(0-t). The model will include a fixed effect for treatment and body weight as a covariate. All other PK parameters will not be subject to inferential statistical analysis. Estimates of geometric mean ratios together with the corresponding 90% confidence intervals (CI) will be derived for the comparisons of the PK parameters as follows: MB02-SP versus MB02-DM MB02-SP versus US Avastin® MB02-DM versus US Avastin® PK similarity will be achieved if the 90% CIs for the biosimilar-to-reference ratios of PK endpoints (AUC[0-?] and Cmax) fall within the predefined 0.80-1.25 acceptance similarity criteria for all 3 pairwise comparisons; MB02-SP versus MB02-DM; MB02-SP versus US Avastin®; and MB02-DM versus US Avastin®. All AEs will be listed and summarised using descriptive methodology. All observed or patient-reported AEs will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The incidence of AEs for each treatment will be presented by severity and by association with the study drugs as determined by the Investigator (or designee). Each AE will be coded using the Medical Dictionary for Regulatory Activities. All safety data will be listed and summarised as appropriate. Immunogenicity data (overall ADA incidence and titters, and neutralising ADA results) will be listed. A summary of the number and percent of subjects testing positive for ADA or neutralising antibodies before the dose of MB02-SP, MB02-DM, or US Avastin® (Day -1) and at scheduled post dose assessments will be presented by treatment arm. All safety data and immunogenicity data summaries will be based on the safety analysis population. Select analyses may be repeated for subsets with or without ADA and de novo ADA formation as appropriate.

Tracking Information