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Clinical Development LEE011/MEK162 Clinical Trial Protocol CMEK162X2114 A phase Ib/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma Document type Amended Protocol Version EUDRACT number 2012-004104-35 Version number 03 (Clean) Development phase Ib/II Document status Final Release date 26-Aug-2015 Property of Array BioPharma Array BioPharma Page 2 Amended Protocol Version 03 (Clean) Protocol No. CMEK162X2114 Table of contents Table of contents ................................................................................................................. 2 List of appendices ................................................................................................................ 6 List of figures ...................................................................................................................... 7 List of tables ........................................................................................................................ 7 List of abbreviations ............................................................................................................ 9 Amendment 3 .................................................................................................................... 12 Summary of previous amendments ................................................................................... 16 Glossary of terms ............................................................................................................... 26 Protocol summary: ............................................................................................................. 27 1 Background ........................................................................................................................ 31 1.1 Overview of disease pathogenesis, epidemiology and current treatment .............. 31 1.2 Introduction to investigational treatment(s) and other study treatment(s)............. 32 1.2.1 Overview of LEE011 ............................................................................ 32 1.2.2 Overview of MEK162 ........................................................................... 35 2 Rationale ............................................................................................................................ 41 2.1 Study rationale and purpose................................................................................... 41 2.2 Rationale for the study design ............................................................................... 41 2.3 Rationale for dose and regimen selection .............................................................. 42 2.4 Rationale for choice of combination drugs ............................................................ 43 3 Objectives and endpoints ................................................................................................... 43 4 Study design ...................................................................................................................... 45 4.1 Description of study design ................................................................................... 45 4.2 Timing of interim analyses and design adaptations ............................................... 47 4.3 Definition of end of the study ................................................................................ 47 4.4 Early study termination.......................................................................................... 47 5 Population .......................................................................................................................... 47 5.1 Patient population .................................................................................................. 47 5.2 Inclusion criteria .................................................................................................... 48 5.3 Exclusion criteria ................................................................................................... 49 6 Treatment ........................................................................................................................... 51 6.1 Study treatment ...................................................................................................... 51 6.1.1 Dosing regimen and treatment administration ...................................... 51 6.1.2 Treatment duration ................................................................................ 53 6.2 Dose escalation guidelines ..................................................................................... 53 6.2.1 Starting dose rationale ........................................................................... 53 Array BioPharma Page 3 Amended Protocol Version 03 (Clean) Protocol No. CMEK162X2114 6.2.2 Provisional dose levels .......................................................................... 53 6.2.3 Criteria for dose escalation and determination of MTD/RP2D ............ 54 6.2.4 Definitions of dose limiting toxicities (DLTs) ...................................... 56 6.3 Dose modification .................................................................................................. 58 6.3.1 Dose modification and dose delays ....................................................... 58 6.4 Concomitant medications ...................................................................................... 65 6.4.1 Prohibited concomitant therapy ............................................................ 65 6.4.2 Permitted concomitant therapy requiring caution and/or action ........... 65 6.4.3 Permitted concomitant therapy ............................................................. 66 6.5 Subject numbering, treatment assignment or randomization ................................ 67 6.5.1 Subject numbering ................................................................................ 67 6.5.2 Treatment assignment ........................................................................... 67 6.5.3 Treatment blinding ................................................................................ 67 6.6 Study drug preparation and dispensation ............................................................... 67 6.6.1 Study drug packaging and labeling ....................................................... 68 6.6.2 Drug supply and storage ........................................................................ 68 6.6.3 Study drug compliance and accountability ........................................... 68 6.6.4 Disposal and destruction ....................................................................... 69 7 Visit schedule and assessments ......................................................................................... 69 7.1 Study flow and visit schedule ................................................................................ 69 7.1.1 Pre-screening assessments .................................................................... 76 7.1.2 Screening ............................................................................................... 76 7.1.3 Treatment period ................................................................................... 77 7.1.4 End of treatment visit ............................................................................ 77 7.1.5 Follow-up period ................................................................................... 78 7.2 Assessment types ................................................................................................... 79 7.2.1 Efficacy assessments ............................................................................. 79 7.2.2 Safety and tolerability assessments ....................................................... 80 7.2.3 Pharmacokinetics .................................................................................. 86 CCI 89 8 Safety monitoring and reporting ........................................................................................ 91 8.1 Adverse events ....................................................................................................... 91 8.1.1 Definitions and reporting ...................................................................... 91 8.1.2 Laboratory test abnormalities ................................................................ 92 8.1.3 Adverse events of special interest ......................................................... 92 8.2 Serious adverse events ........................................................................................... 93 Array BioPharma Page 4 Amended Protocol Version 03 (Clean) Protocol No. CMEK162X2114 8.2.1 Definitions ............................................................................................. 93 8.2.2 Reporting ............................................................................................... 93 8.3 Pregnancies ............................................................................................................ 94 8.4 Warnings and precautions...................................................................................... 95 8.5 Data Safety Monitoring Board............................................................................... 95 8.6 Steering Committee ............................................................................................... 95 9 Data collection and management ....................................................................................... 96 9.1 Data confidentiality ..............................................................................................
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