Substantial Amendment 10 and 11 Back to 'For participating sites' SA10 REC Cover Letter dated 24-Jul-2017 SA10 HRA email confirmation of REC validation and categorisation dated 02-Aug-2017 SA10 REC Valid Notice of Substantial Amendment dated 02-Aug-2017 (reissued 04-Aug-2017) SA10 REC Favourable Opinion of Amendment dated 07-Aug-2017 SA10 MHRA Cover Letter dated 24-Jul-2017 SA10 MHRA Acknowledgement of Amendment dated 27-Jul-2017 SA10 MHRA Notice of Non Acceptance of Amendment dated 24-Aug-2017 SA11 MHRA Cover Letter dated 13-Sep-2017 SA11 MHRA Acknowledgement of Amendment dated 18-Sep-2017 SA11 MHRA Notice of Acceptance of Amendment dated 20-Sep-2017 SA11 HRA email confirmation of amendment categorisation dated 20-Sep-2017 SA10 & SA11 HRA Approval email dated 22-Sep-2017 Protocol v5.0a dated 29-Aug-2017 Protocol Synopsis v5.0 dated 04-Jul-2017 SA10 Summary of Protocol Changes v1.0 dated 04-Jul-2017 SA10 Summary of Patient Document Changes v1.0 dated 23-May-2017 Arm A AZD4547 PIS & ICF v6.0 dated 23-May-2017 Arm B Vistusertib PIS & ICF v6.0 dated 23-May-2017 Arm C Palbociclib PIS & ICF v6.0 dated 23-May-2017 Arm D Crizotinib PIS & ICF v6.0 dated 23-May-2017 Arm E Selumetinib & Docetaxel PIS & ICF v6.0 dated 23-May-2017 Arm F AZD5363 PIS & ICF v3.0 dated 23-May-2017 Arm NA Cohort NA1 Durvalumab PIS & ICF v6.0 dated 23-May-2017 Arm B Addendum B to PIS & ICF v1.0 dated 23-May-2017 Arm C Addendum B to PIS & ICF v1.0 dated 23-May-2017 Arm F Addendum B to PIS & ICF v1.0 dated 23-May-2017 Arm D Crizotinib Patient Diary v4.0 dated 23-May-2017 Arm A AZD4547 GP Letter v6.0 dated 23-May-2017 Arm B Vistusertib GP Letter v6.0 dated 23-May-2017 Arm C Palbociclib GP Letter v6.0 dated 23-May-2017 Arm D Crizotinib GP Letter v6.0 dated 23-May-2017 Arm E Selumetinib & Docetaxel GP Letter v6.0 dated 23-May-2017 Arm F AZD5363 GP Letter v3.0 dated 23-May-2017 Arm NA Cohort NA1 Durvalumab GP Letter v6.0 dated 23-May-2017 Release of Medical Information Form v4.0 dated 23-May-2017 Docetaxel IMP Label v2.0 dated 15-May-2017 Palbociclib IMP Label v1.0 dated 15-May-2017 Pharmacy Manual v5.0 dated 21-Aug-2017 Example IMP Labels v5.0 dated 22-Aug-2017 Registration Form v5.0 dated 23-Aug-2017 Core Eligibility Checklist v4.0 dated 23-Aug-2017 Arm A Eligibility Checklist v5.0 dated 23-Aug-2017 Arm B Eligibility Checklist v4.0 dated 23-Aug-2017 Arm C Eligibility Checklist v6.0 dated 23-Aug-2017 Arm D Eligibility Checklist v5.0 dated 23-Aug-2017 Arm E Eligibility Checklist v4.0 dated 23-Aug-2017 Arm F Eligibility Checklist v3.0 dated 23-Aug-2017 Arm NA Cohort NA1 Eligibility Checklist v5.0 dated 23-Aug-2017