SA-05

Summary of Changes

Protocol version has changed from version 4.0 dated 06 Oct 2014 to version 5.0a dated 23 September 2015.

Changes include:

1. Addition of two new randomisation arms (topotecan + temozolomide and topotecan+ temozolomide+bevacizumab)
2. Changes to the eligibility criteria (including explanation of contraceptive methods and time between last IMP administration)
3. Confirmatory scans removed
4. Samples for biomarker analysis taken at additional time points (cycle 2, cycle 4, cycle 6)
5. Details of Switzerland lead investigator added
6. Lead investigator for France changed

• SA-05 Notification of a Substantial Amendment [pdf]
• SA-05 MHRA Approval [.pdf]
  
• SA-05 MHRA Cover letter [.pdf]
• SA-05 REC Approval  [pdf]
• SA-05 REC Cover letter  [pdf]

A full list of changes can be found in the Protocol version 5.0a dated 23 September 2015.