BP25389-Ph I RO5323441 combined with bevacizumab vs bevacizumab alone

• Research type

  Research Study

• Full title

  Open-label, combined dose-finding and efficacy-finding study of RO5323441 in combination with bevacizumab for patients with recurrent glioblastoma.

• IRAS ID

  63790

• Contact name

  Catherine McBain

• Sponsor organisation

  F. Hoffmann-La Roche AG Pharma Research & Early Development (pRED)

• Eudract number

  2010-021795-29

• Research summary

  A Phase I/II Open-label, combined dose-finding and efficacy-finding study of RO5323441 in combination with bevacizumab for patients with recurrent glioblastoma to establish the safe dose of RO5323441 in combination with bevacizumab and to determine the treatment benefit of RO5323441 combined with bevacizumab as compared to bevacizumab alone in terms of hazard ratio of PFS, and to evaluate the correlation of biomarkers with clinical activity and/or adverse events associated with study treatment, Investigate PK-PD relationships with respect to PD effect (DCE-MRI and other biomarkers), safety, and time course of tumor size measurements using exploratory graphical analysis and also PK-PD modeling techniques if possible, and to evaluate the clinical effect of addition of RO5323441 to bevacizumab thearapy at disease progression of patients enrolled in the bevacizumab monotherapy arm of the Efficacy-Finding part of the study, and to further investigate the predictive value of drug induced change in tumor size as a predictor/biomarker for clinical efficacy (PFS), and to increase our knowledge and understanding of disease biology.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  10/H1003/113

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Further Information Favourable Opinion