Please ensure that you have obtained local R&D approval for this amendment before using these documents. All documents require a username and password login to access; please contact the Trial Office if you require these.
- SA21 MHRA Approval Documents v1.0 [PDF, 394 KB]
- SA121 HRA Approval Documents v1.0 [PDF, 98 KB]
- SA21 REC Approval Documents v1.0 [PDF, 422 KB]
- Trial Protocol v10.0 04-Dec-2020 CLEAN [PDF, 5.06 MB]
- Trial Protocol Synopsis 10.0 04-Dec-2020 CLEAN [PDF, 143 KB]
- Arm C: Palbociclib – PIS & ICF v10.0a 11-Jan-21 CLEAN [Word, 244 KB]
- Arm C:Palbociclib-Patient Diary v4.0_15-May-2021 CLEAN [Word, 102 KB]
- Arm E: Selumetinib & Docetaxel – PIS & ICF v9.0 13-Oct-20 CLEAN [Word, 482 KB]
- Arm J: AZD6738 & Durvalumab – PIS & ICF v2.0 13-Oct-20 [Word, 553 KB]
- Arm J: AZD6738 & Durvalumab – eligibility Checklist v2.0 24-Jul-2020 [PDF, 256 KB]
- Treatment Form v2.0 19-Oct-2020 [PDF, 89 KB]
- SAE Form v70 29-Apr-2020 [PDF, 282 KB]
- SAE Form Completion guidelines v6.0 11-May-2021 [PDF, 148 KB]
- Pharmacy Manual v11.0 14-Jan-2021 [PDF, 1.17MB]
Please note: Investigators Brochures (IBs) will be sent to sites via email.
Please note: Patient Documents should be localised using hospital headed paper.