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