Substantial Amendment 13-14 Back to 'For participating sites' All documents are pdf unless otherwise specified and require username and password login to access. SA13 REC Cover Letter dated 04-May-2018 SA13 REC Favourable Opinion of Amendment dated 18 May 2018 SA13 MHRA Cover Letter dated 01-may-2018 SA13 MHRA Notice of Non Acceptance of Amendment dated 04-Jun-2018 SA14 MHRA Cover Letter dated 18-Jun-2018 SA14 MHRA Acknowledgement of Amendment dated 21-Jun-2018 SA14 MHRA Notice of Acceptance of Amendment dated 24-Jul-2018 SA14 HRA email confirmation of amendment categorisation dated 09-Oct-2018 Protocol v6.0a dated 06-Sep-2018 Protocol Synopsis v6.0 dated 27-Apr-2018 SA13 Summary of Protocol v6.0 Changes v2.0 dated 27-Apr-2018 SA13 Summary of Patient Document Changes v2.0 dated 27-Apr-2018 Arm A AZD4547 PIS & ICF v7.0 dated 28-Mar-2018 Arm B Vistusertib PIS & ICF v7.0 dated 28-May-2018 Arm C Palbociclib PIS & ICF v7.0 dated 28-May-2018 Arm D Crizotinib PIS & ICF v7.0 dated 28-Mar-2017 Arm E Selumetinib & Docetaxel PIS & ICF v7.0 dated 09-Apr-2018 Arm F AZD5363 PIS & ICF v4.0 dated 28-Mar-2018 Arm H Sitravatinib PIS & ICF v1.0 dated 27-Apr-2018 Research Model Biopsy PIS & ICF v1.0 dated 28-Mar-2018 Pharmacodynamic Biopsy PIS & ICF v1.0 dated 28-Mar-2018 Arm C Addendum A to PIS & ICF v1.0a dated 23-May-2017 Arm D Crizotinib Patient Diary v5.0 dated 27-Apr-2018 Arm E Selumetinib & Docetaxel Patient Diary v4.0 dated 27-Apr-2018 Arm H Sitravatinib Patient Diary v1.0 dated 23-Mar-2018 Arm A AZD4547 GP Letter v7.0 dated 29-Mar-2018 Arm B Vistusertib GP Letter v7.0 dated 29-Mar-2018 Arm C Palbociclib GP Letter v7.0 dated 29-Mar-2018 Arm D Crizotinib GP Letter v7.0 dated 12-Apr-2018 Arm E Selumetinib & Docetaxel GP Letter v7.0 dated 09-Apr-2018 Arm F AZD5363 GP Letter v4.0 dated 10-Apr-2018 Arm H Sitravatinib GP Letter v1.0 dated 09-Apr-2018 Release of Medical Information Form v5.0 dated 23-Mar-2018 Pharmacy Manual v7.0 dated 15-Aug-2018 Example IMP Labels v5.0 dated 22-Aug-2017 Registration Form v6.0 dated 10-Apr-2018 Core Eligibility Checklist v5.0 dated 24-Jul-2018 Arm A Eligibility Checklist v6.0 dated 24-Jul-2018 Arm B Eligibility Checklist v5.0 dated 24-Jul-2018 Arm C Eligibility Checklist v7.0 dated 24-Jul-2018 Arm D Eligibility Checklist v6.0 dated 24-Jul-2018 Arm E Eligibility Checklist v5.0 dated 24-Jul-2018 Arm F Eligibility Checklist v4.0 dated 24-Jul-2018 Arm H Eligibility Checklist v1.0 dated 24-Jul-2018 Arm A AZD4547 IB/SPc dated 27-Jul-2015 Arm B Vistusertib IB/SPc dated 16-Dec-2016 Arm C Palbociclib IB/SPc dated Jul-2017 Arm D Crizotinib IB/SPc dated 01-Jan-2018 Arm E Docetaxel IB/SPc dated 29-May-2015 Arm E Selumetinib IB/SPc dated 31-Jan-2017 Arm F AZD5363 IB SPc dated 14-Dec-2016 Arm H Sitravatinib IB/SPc 11-Sep-2017 SAE Form v6.0 dated 24-Jul-2018 Arm A-H Vital Signs Form v1.0 dated 10-Apr-2018 Arm A-H Treatment Form v1.0 dated 10-Apr-2018 Arm B Lab Tests Form v4.0 dated 10-Apr-2018 Arm D Lab Tests Form v4.0 dated 10-Apr-2018 Arm E Lab Tests Form v4.0 dated 10-Apr-2018 Arm H Lab Tests Form v1.0 dated 10-Apr-2018 Arm A Ophthalmology Exam Form v3.0 dated 10-Apr-2018 Arm D Ophthalmology Exam Form v2.0 dated 10-Apr-2018 Arm E Sel & Doc Ophthalmology Exam Form v3.0 10-Apr-2018 ECG Form v6.0 dated 10-Apr-2018 ECHO MUGA Form v4.0 dated 10-Apr-2018 Physical Exam Form v4.0 dated 10-Apr-2018 Arm H Sitravatinib Drug Order Form v1.0 dated 26-Jun-2018 Arm H Sitravatinib Prescription Form v1.0 dated 16-Jul-2018 SAE Completion guidelines v4.0 dated 27-Feb-2018 Disease History Form v1.0 dated 10-Apr-2018 Concomitant Radiotherapy Form v1.0 dated 11-May-2017 Screening Registration Form v4.0 dated 14-Jun-2018 Cohort Allocation Form v3.0 dated 14-Jun-2018 eRDC User Manual v3.0 dated 24-Jul-2018 Laboratory Manual v6.0 dated 18-Sep-2018 Prohibited and Concomitant Medications document v3.0 dated 17-Aug-2018