Substantial Amendment 10 and 11

  • 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