eNERGY Protocole signe V2.0 2017.11.06.pdf


Preview of PDF document energy-protocole-signe-v2-0-2017-11-06.pdf

Page 1 2 34560

Text preview


ENERGY

Trial Code Sponsor 35RC16_9734 / GFPC 08-2015 / BMS CA209-449

TABLE OF CONTENTS

1

GENERAL INFORMATION .................................................................................................................. 17
1.1. Title ............................................................................................................................................................ 17
1.2.
Sponsor ................................................................................................................................................. 17
1.3.
Coordination and monitoring of study .................................................................................................. 17
1.4.
Investigators .......................................................................................................................................... 17
1.5.
Pharmacy............................................................................................................................................... 17
1.6.
Pharmacovigilance ................................................................................................................................ 17
1.7.
Methodologist – biostatistician ............................................................................................................. 18
1.10. Efficacy evaluation committee ............................................................................................................. 18
1.11. Data monitoring committee .................................................................................................................. 18
2
SCIENTIFIC RATIONALE AND GENERAL DESCRIPTION OF STUDY.................................... 19
2.1. Name and description of investigational medicinal products .................................................................... 19
2.2. Summary of results of non-clinical trials and clinical trials available and relevant regarding the
research involving the human person study concerned .................................................................................... 19
2.3 Summary of benefits and of foreseeable and known risks for the person who is a Patient in the research
study ............................................................................................................................................................... 25
2.3.1 Benefits ................................................................................................................................................. 25
2.3.1.1 Individual benefits ......................................................................................................................... 25
2.3.1.2 Collective benefit .......................................................................................................................... 25
2.3.2 Risks ..................................................................................................................................................... 25
Individual risks.......................................................................................................................................... 25
2.4. Description and rationale for route of administration, dosage, administration regimen and duration of
treatment ........................................................................................................................................................... 25
2.5. Statement indicating that the study will be conducted in compliance with the protocol as well as with
good clinical practices and legislative and regulatory conditions in force ....................................................... 26
2.6. Description of the studied population ........................................................................................................ 26
2.7. References to the scientific literature and to relevant data used as a reference for the study .................... 26
3
STUDY OBJECTIVES............................................................................................................................. 27
3.1. Primary objective ....................................................................................................................................... 28
3.2. Secondary objectives ................................................................................................................................. 28
4
STUDY DESIGN ....................................................................................................................................... 28
4.1 Evaluation criteria ....................................................................................................................................... 28
4.1.1 Primary evaluation criteria ................................................................................................................. 28
4.1.2. Secondary evaluation criteria ............................................................................................................. 28
4.2. Description of study methodology ............................................................................................................. 28
4.2.1. Experimental design............................................................................................................................ 28
4.2.2. Conduct of study ................................................................................................................................. 28
4.2.2.1. Inclusion Assessments and Procedures ....................................................................................... 30
4.2.2.2. On-Study Assessments and Procedures ........................................................................................ 30
4.2.2.3 Post progression Assessments and Procedures............................................................................. 31
4.2.2.4 Study Flow-chart ........................................................................................................................... 32
4.3. Description of the measures taken to reduce and prevent bias .................................................................. 34
4.3.1. Randomisation .................................................................................................................................... 34
4.3.2. Methods of blinding ............................................................................................................................ 34
4.4. Description of dosage and methods of administration of the investigational medicinal products.
Description of dose unit form, packaging and labelling of the investigational medicinal product(s) .............. 34
4.5. Expected duration of participation of persons and description of chronology and of duration of all
study periods including monitoring .................................................................................................................. 34
Protocole

Version 2.0 du 06/11/2017

Page 3/60