SeluDex: For Investigators

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Site Signature and Delegation Log is updated. Return both documents to the SeluDex Trial Office.

• Investigator Registration Form (Consultants only) [738 KB .doc]
• Site Staff Registration Form (All other staff) [697 KB .doc]

Links to the current Protocol, Patient Information Sheets and Informed Consent Forms are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Forms, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the SeluDex Trial Office.

• Trial Protocol [4,466 KB .pdf]
• Trial Summary [387 KB .pdf]

Patient Documents

Patient Information Sheets 

Pre-trial Genetic Assessment (RAS mutation testing)

• Adult Pre-trial Genetic Assessment PIS [2,799 KB .doc]
• Parent/Guardian Pre-trial Genetic Assessment PIS [2,800 KB .doc]
• 13-15yrs Pre-trial Genetic Assessment PIS [2,795 KB .doc]
• 8-12yrs Pre-trial Assessment PIS [2,814 KB .doc]

Phase I (Dose Finding)

• Adult Phase I Dose Finding PIS [2,825 KB .doc]
• Parent/Guardian Phase I Dose Finding PIS [2,827 KB .doc]
• 13-15yrs Phase I Dose Finding PIS [2,816 KB .doc]

Phase II (Dose Expansion)

• Adult Phase II Dose Expansion PIS [2,824 KB .doc]
• Parent/Guardian Phase II Dose Expansion PIS [2,826 KB .doc]
• 13-15yrs Phase II Dose Expansion PIS [95 KB .doc]

Phase I & II (Dose Finding & Expansion)

• 8-12yrs Phase I & II Dose Finding & Expansion PIS [756 KB .doc]

16 Year Old Re-consent

• Age of Majority PIS Cover Letter [1,307 KB .doc]

Informed Consent Forms

Pre-trial Genetic Assessment (RAS mutation testing)

• Adult Pre-trial Genetic Assessment ICF [123 KB .doc]
• Parent/Guardian Pre-trial Genetic Assessment ICF [168 KB .doc]

Phase I (Dose Finding)

• Adult Phase I Dose Finding ICF [722 KB .doc]
• Parent/Guardian Phase I Dose Finding ICF [723 KB .doc]

Phase II (Dose Expansion)

• Adult Phase II Dose Expansion ICF [731 KB .doc]
• Parent/Guardian Phase II Dose Expansion ICF [729 KB .doc]

GP Letters

• Group A (Adult) Phase I Escalation GP Letter [695 KB .doc]
• Group P (Paediatric) Phase I Escalation GP Letter [694 KB .doc]
• Group A (Adult) Phase II Expansion GP Letter [695 KB .doc]
• Group P (Paediatric) Phase II Expansion GP Letter [695 KB .doc]

Patient Diaries

• Patient Diary Cycle 1 Only [333 KB .pdf]
• Patient Diary Cycle 2 Only [324 KB .pdf]
• Patient Diary Cycles 3-6 [323 KB .pdf]

Other 

• Patient ID Card [83 KB .pdf]
• Concomitant Medication & Restrictions Patient Card [340 KB .pdf]
• Release of Medical Information Form [68 KB .doc]

Serious Adverse Event / Dose Limiting Toxicity Reporting

• SAE Form [722 KB .pdf]
• SAE Form Completion Guidelines [223 KB .pdf]
• Suspected DLT Form [850 KB .pdf]

Investigator Brochure & Summaries of Product Characterisitics

The latest Investigator’s Brochures and Summary of Product Characteristics provided to the SeluDex Trial Office are available below. Please ensure the latest versions are available in both the Investigator Site File and Pharmacy File. Whilst all the latest Investigator’s Brochures and Summary of Product Characteristics are provided to sites immediately for their reference, these will be submitted yearly to the MHRA by substantial amendment ahead of the DSUR deadline in May.

• Selumetinib IB (please contact the trial office for this document)
• Dexamethasone Tablets SmPC [133 KB .pdf]
• Dexamethasone Liquid SmPC [141 KB .pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below.

• Investigator Site File Version Control List [129 KB .pdf]
• Pharmacy File Version Control List [333 KB .pdf]
• National Coordinating Centre Version Control List [106 KB .pdf]

Regulatory Approvals

Below is a link to a new page containing all of the regulatory approval documents including information on all amendments which have been made for this trial. 

• Regulatory Approval Documents [new page]

Case Report Form

• Case Report Forms [new page]

Sample Collection

Site specific versions of Sample Collection Forms, further supplies of Laboratory Consumables and Sample Labels are available from the SeluDex Trial Office.

• RAS Mutation Sample Form [482 KB .pdf]
• PK Sample Form [537 KB .pdf]
• PD-RNA Sample Form [301 KB .pdf]
• PD-Fixed Sample Form [301 KB .pdf]
• Group A MRD Testing Sample Form [297 KB .pdf]
• Sample Temperature Log [117 KB .pdf]

Guidelines & Other Trial Documents

• Pharmacy Manual [1,594 KB .pdf]
• Selumetinib Drug Request Form - UK Supply [66 KB .doc]
• Selumetinib Drug Request Form - International Supply [67 KB .doc]
• Laboratory Manual [1,457 KB .pdf]
• CRF Completion Guidelines [474 KB .pdf]
• eRDC User Manual [2,127 KB .pdf]
• On-site Temperature Deviation Form [361 KB .pdf]
• In Transit Temperature Deviation Form [113 KB .pdf]

To date there are no publications available for this trial

There is no current news or events for this trial

Chief Investigator

Dr Tobias Menne
Consultant Haematologist
Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK, NE7 7DN

Tel: +44 (0)191 213 8659

International Lead Investigator

Professor Josef Vormoor
Consultant Paediatric Haematologist
Princess Maxima Center for Pediatric Oncology, 3584 EA Utrecht, The Netherlands

SeluDex Trial Office

Trial Coordinator                                 

Sarah Johnson

Trial Monitor                                       

Jennifer Keely

Trial Management Team Leader

Joshua Savage

Trial Statistician

Grace Holt

Cancer Research UK Clinical Trials Unit (CRCTU), Department of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, UK, B15 2TT

Enquiries

Telephone: +44 (0) 121 414 6754
Email: seludex@trials.bham.ac.uk

Trial Entry Registration

Email: seludex@trials.bham.ac.uk

Serious Adverse Event Reporting

Email: reg@trials.bham.ac.uk

Sponsor

University of Birmingham, Edgbaston, Birmingham, UK, B15 2TT

CRCTU Home Page

http://www.birmingham.ac.uk/crctu