ph 2 3 trial for selepressin in the treatment of
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Ph#2/3#Trial#for#Selepressin#in# the#Treatment#of#Vasopressor6# - PowerPoint PPT Presentation

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Ph#2/3#Trial#for#Selepressin#in# the#Treatment#of#Vasopressor6# Dependent#Sep9c#Shock# # Sco<#Berry,#PhD ! December#4,#2014 # Trial#Basics# Selepressin:# selec9ve#vasopressin#V1a#agonist#for#treatment#of#

  1. Ph#2/3#Trial#for#Selepressin#in# the#Treatment#of#Vasopressor6# Dependent#Sep9c#Shock# # Sco<#Berry,#PhD ! December#4,#2014 #

  2. Trial#Basics# • Selepressin:# – selec9ve#vasopressin#V1a#agonist#for#treatment#of# vasopressor6dependent#sep9c#shock# • Arms#created#by#level#of#concentra9on#–# allowing#mul9ple#“doses”#to#be#blinded#and# infusion#rates#can#vary:# Treatment!! Star,ng!Dose! Maximum!Dose! Arm! (ng/kg/min)! (ng/kg/min)! 0# 0# 0# 1# 1.7# 2.5# 2# 2.5# 3.75# 3# 3.5# 5.25# 2! 4# Dec#4,#2014# 5.0# 7.5#

  3. Trial#Basics# • Double6blind,#placebo6controlled# • “Pivotal#Trial”#Endpoint# – Composite#mortality/morbidity#endpoint# 3! Dec#4,#2014#

  4. Possible#Phase#2?# • 200#pa9ent#study#of#a#“biomarker”#for#dose# selec9on#(2#arms#given#fixed#nature?)# – Then#phase#III# • 400#pa9ent#trial#of#doses#on#primary#endpoint# to#select#dose#and#make#phase#3#go/no6go# – Then#phase#III# • 800#pa9ent#trial#of#doses#on#primary#endpoint# to#select#dose#and#make#phase#3#go/no6go# – Then#phase#III# 4! Dec#4,#2014#

  5. Adap9ve#Phase#2# Part#2# Part#1# Burn6In# RAR# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# ##############Phase#26like# 5! Dec#4,#2014#

  6. Part#1:#Burn6In# Part#2# Part#1# Burn6In# RAR# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Start#with#3#doses#+#PBO#during#200#pa9ent# burn6in# – 3:2:2:2:0##(Arms#0:1:2:3:4)# 6! Dec#4,#2014#

  7. Part#1:#Adap9ve# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Interims#occur#from#2006800#con9nue# monthly#for#Part#1# – Create#response#adap9ve#randomiza9on#over# ac9ve#arms#(1/3#:#?#:#?#:#?#:#?)#for#next#month# – Fu9lity#/#Go#to#Part#2#decisions# 7! Dec#4,#2014#

  8. Part#2:#Confirm# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Enroll#1:1#to#PBO#and#selected#‘target’#dose#to# make#the#final#sample#size#1800# – Part#2#minimum#is#1000#pa9ents# – Fu9lity#analyses#every#month# 8! Dec#4,#2014#

  9. Part#1:#RAR# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Randomiza9on#probability#propor9onal#to#the# probability#the#arm#maximizes#the#effect#on#the# primary#endpoint# – Open#“Arm#4”#if#≥#50%#probability#Arm#3#has#be<er# effect#on#the#primary#endpoint#than#Arm#2.# 9! Dec#4,#2014#

  10. Part#1:#Decisions# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Go#to#Part#2#if#(n≥300)# – Predic9ve#probability#of#superiority#@#1800#with# most#likely#maximum#dose#≥#90%# 10! Dec#4,#2014#

  11. Part#1:#Decisions# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Stop#for#fu9lity#if# – Predic9ve#probability#of#superiority#@#1800#with# most#likely#maximum#dose#<#5%# 11! Dec#4,#2014#

  12. Part#1:#n=800#Decision# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Go#to#Part#2#if#(n=800)# – Predic9ve#probability#of#superiority#@#1800#with# most#likely#maximum#dose#≥#25%# – If#not#stop#the#trial# 12! Dec#4,#2014#

  13. Final#Analysis# Part#2# Part#1# Burn6In# Adap9ve# PBO# Arm#1# Arm#2# Arm#3# Arm#4# 200# 800# 1800# • Pool#all#selepressin#arms#(Part#1#&#Part#2)#in# final#analysis#vs.#PBO#with#Wilcoxon#Test#(Van# Elteren’s)#at#the#0.025#level# • Type#I#error#controlled#analysis#of#superiority# 13! Dec#4,#2014#

  14. Bayesian#Sta9s9cal#Model# • Sta9s9cal#model#to#drive#all#adapta9ons# • Model#mixture#of#death#and#morbidity# outcome#for#survivors# – Propor9onal#effect#for#selepressin#treatment#arms# ( α 1 ,…, α 4 )# • Model#for#morbidity#for#survivors# – Propor9onal#effect#for#selepressin#treatment#arms# ( θ 1 ,…, θ 4 )# • Inverted#U6Dose6Response#models## 14! Dec#4,#2014#

  15. Opera9ng#Characteris9cs# Prop.!Of!Trials! Mean!Sample!Size! Scenario! Target! (Effect)! Success! Part!2! 1800! Total! Part!1! Part!2! Dose! 0# .016# .148# .043# 770.5# 638.6# 131.9# 709.5# A# .127# .370# .187# 1069.4# 694.6# 374.8# 712.2# B# .497# .680# .569# 1442.2# 665.6# 776.6# 741# C# .854# .895# .875# 1690.3# 582.4# 1107.9# 756.5# D# .983# .986# .985# 1785.2# 501.6# 1283.6# 776.5# E# 1# 1# 1# 1800# 441# 1359# 796.1# F# 1# 1# 1# 1800# 438.3# 1361.7# 806.1# 15! Dec#4,#2014#

  16. Individual#Scenarios# Prop!of!Trials! Mean!Sample!Size! True! Arm! Target!&! Effect! Target! Total! Part!1! Part!2! Win! PBO! 0! 0! 0! 638.6! 131.9! 709.5! Dose#1# C# .194# .181# 694.6# 374.8# 712.2# Dose#2# C# .456# .440# 665.6# 776.6# 741# Dose#3# C# .234# .225# 582.4# 1107.9# 756.5# Dose#4# C# .011# .008# 501.6# 1283.6# 776.5# PBO! 0! 0! 0! 618.8! 178.9! 439.9! Dose#1# A# .021# .011# 185.2# 173.2# 12.0# Dose#2# B# .206# .155# 266.9# 142.6# 124.3# Dose#3# C# .432# .390# 362.0# 109.7# 252.3# Dose#4# C# .093# .085# 96.8# 45.8# 51.0# PBO! 0! 0! 0! 701.8! 164.3! 537.5! Dose#1# C# .317# .292# 402.6# 215.2# 187.4# Dose#2# C# .489# .468# 427.2# 123.6# 303.6# Dose#3# B# .077# .053# 124.6# 78.1# 46.5# Dose#4# A# 0# 0# 13.4# 13.4# 0# 16! Dec#4,#2014#

  17. Simula9on# • Trial#conducted#through#extensive#simula9ons# – Example#trials,#cut6offs,#modeling,#sample#sizes,# power,#dose#selec9on,#etc…# type'I'error'' • Example#of#value#of#simula9ons#for#fu9lity# thresholds#prospec9vely…# 17! Dec#4,#2014#

  18. Primary Endpoint Part 1 Futility = 0 Failed at N=1800 : 3356 Futile, Would Have Lost Anyway : 0 4 Futile for Other Reason : 0 1.2 Failed at N=1800 : 3356 Futile, Would Have Won : 0 Success : 6644 Success : 6644 Futile, Would Have Lost Anyway : 0 Futile, Would Have Won : 0 Futile for Other Reason : 0 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  19. Primary Endpoint Part 1 Futility = 0.01 Failed at N=1800 : 3007 Futile, Would Have Lost Anyway : 349 4 Futile for Other Reason : 0 1.2 Failed at N=1800 : 3007 Futile, Would Have Won : 0 Success : 6644 Success : 6644 Futile, Would Have Lost Anyway : 349 Futile, Would Have Won : 0 Futile for Other Reason : 0 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  20. Primary Endpoint Part 1 Futility = 0.05 Failed at N=1800 : 2401 Futile, Would Have Lost Anyway : 955 4 Futile for Other Reason : 0 1.2 Failed at N=1800 : 2401 Futile, Would Have Won : 35 Success : 6609 Success : 6609 Futile, Would Have Lost Anyway : 955 Futile, Would Have Won : 35 Futile for Other Reason : 0 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  21. Primary Endpoint Part 1 Futility = 0.1 Failed at N=1800 : 1963 Futile, Would Have Lost Anyway : 1393 4 Futile for Other Reason : 0 1.2 Failed at N=1800 : 1963 Futile, Would Have Won : 102 Success : 6542 Success : 6542 Futile, Would Have Lost Anyway : 1393 Futile, Would Have Won : 102 Futile for Other Reason : 0 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  22. Primary Endpoint Part 1 Futility = 0.15 Failed at N=1800 : 1642 Futile, Would Have Lost Anyway : 1714 4 Futile for Other Reason : 0 1.2 Failed at N=1800 : 1642 Futile, Would Have Won : 193 Success : 6451 Success : 6451 Futile, Would Have Lost Anyway : 1714 Futile, Would Have Won : 193 Futile for Other Reason : 0 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  23. (Part 1 Rule = 0.05) Primary Endpoint, N=800 Futility = 0 Failed at N=1800 : 2401 Futile, Would Have Lost Anyway : 0 4 Futile for Other Reason : 990 1.2 Failed at N=1800 : 2401 Futile, Would Have Won : 0 Success : 6609 Success : 6609 Futile, Would Have Lost Anyway : 0 Futile, Would Have Won : 0 Futile for Other Reason : 990 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  24. (Part 1 Rule = 0.05) Primary Endpoint, N=800 Futility = 0.25 Failed at N=1800 : 1600 Futile, Would Have Lost Anyway : 801 4 Futile for Other Reason : 990 1.2 Failed at N=1800 : 1600 Futile, Would Have Won : 117 Success : 6492 Success : 6492 Futile, Would Have Lost Anyway : 801 Futile, Would Have Won : 117 Futile for Other Reason : 990 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

  25. (Part 1 Rule = 0.05) Primary Endpoint, N=800 Futility = 0.3 Failed at N=1800 : 1436 Futile, Would Have Lost Anyway : 965 4 Futile for Other Reason : 990 1.2 Failed at N=1800 : 1436 Futile, Would Have Won : 180 Success : 6429 Success : 6429 Futile, Would Have Lost Anyway : 965 Futile, Would Have Won : 180 Futile for Other Reason : 990 1.0 3 0.8 2 Morbidity Benefit 0.6 1 0.4 0 0.2 − 1 0.0 − 5 0 5 10 0 A B C D E Mortality Benefit

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