A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Phase: PHASE2
Conditions: Head and Neck Cancer
Sponsor: M.D. Anderson Cancer Center

Protocol ID02-668 
Revised April 03, 2025 
Page 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 3

Protocol ID02-668 
Revised April 03, 2025 
Page 4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 6

Protocol ID02-668 
Revised April 03, 2025 
Page 7 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 9 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 10

Protocol ID02-668
Revised April 03, 2025
Page 11

Protocol ID02-668 
Revised April 03, 2025 
Page 12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 14 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 15

Protocol ID02-668 
Revised April 03, 2025 
Page 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 17

Protocol ID02-668
Revised April 03, 2025
Page 18

Protocol ID02-668
Revised April 03, 2025
Page 19

Protocol ID02-668
Revised April 03, 2025
Page 20

Protocol ID02-668
Revised April 03, 2025
Page 21

Protocol ID02-668 
Revised April 03, 2025 
Page 22 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 26 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 27

Protocol ID02-668
Revised April 03, 2025
Page 28

Protocol ID02-668 
Revised April 03, 2025 
Page 29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 30 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 32 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 33 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 34

Protocol ID02-668 
Revised April 03, 2025 
Page 35 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 36 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 37 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
April 03, 2025 
Page 38 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 39 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668
Revised April 03, 2025
Page 41

Protocol ID02-668 
Revised April 03, 2025 
Page 42 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 43 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 44 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol ID02-668 
Revised April 03, 2025 
Page 45