(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Amgen

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Product:  Oprozomib 
Protocol Number:  20160104 
Date:  27 January 2021 
Page 33 of 125 
CONFIDENTIAL 
 
 
Table 2.  Summary of Subject Incidence of Treatment-Emergent Adverse Events (Safety Analysis Set) 
 
Non-roll Over Subjects 
 
ODex 2/7 Schedule 
 
OPomd 2/7 Schedule 
 
 
IR 150 
mg/day 
(N  5) 
n () 
GR 150 
mg/day 
(N  8) 
n () 
ODex 2/7 
Total 
(N  13) 
n () 
 
IR 150 
mg/day 
(N  4) 
n () 
GR 150 
mg/day 
(N  4) 
n () 
IR 200 
mg/day 
(N  8) 
n () 
GR 200 
mg/day 
(N  5) 
n () 
IR 225 
mg/day 
(N  10) 
n () 
IR 250 
mg/day 
(N  8) 
n () 
OPomd 
2/7 Total 
(N  39) 
n () 
Total 
Subjects 
(N  52) 
n () 
All treatment-emergent adverse events 
4 (80.0) 
8 (100.0) 12 (92.3)  4 (100.0) 4 (100.0) 8 (100.0) 5 (100.0) 10 (100.0) 8 (100.0) 39 (100.0) 51 (98.1) 
Grade  2 
4 (80.0) 
8 (100.0) 12 (92.3)  4 (100.0) 4 (100.0) 8 (100.0) 5 (100.0) 10 (100.0) 8 (100.0) 39 (100.0) 51 (98.1) 
Grade  3 
3 (60.0) 
7 (87.5) 
10 (76.9)  4 (100.0) 4 (100.0) 8 (100.0) 5 (100.0) 
8 (80.0) 
6 (75.0) 
35 (89.7) 45 (86.5) 
Grade  4 
1 (20.0) 
1 (12.5) 
2 (15.4)  3 (75.0) 
2 (50.0) 
1 (12.5) 
4 (80.0) 
0 (0.0) 
1 (12.5) 
11 (28.2) 13 (25.0) 
Serious adverse events 
2 (40.0) 
2 (25.0) 
4 (30.8)  2 (50.0) 4 (100.0) 
6 (75.0) 
4 (80.0) 
3 (30.0) 
4 (50.0) 
23 (59.0) 27 (51.9) 
Leading to discontinuation of 
investigational product 
0 (0.0) 
0 (0.0) 
0 (0.0) 
 1 (25.0) 
1 (25.0) 
2 (25.0) 
1 (20.0) 
0 (0.0) 
1 (12.5) 
6 (15.4) 
6 (11.5) 
Fatal adverse events 
0 (0.0) 
0 (0.0) 
0 (0.0) 
 0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (20.0) 
0 (0.0) 
0 (0.0) 
1 (2.6) 
1 (1.9) 
Treatment-related treatment-emergent 
adverse events 
4 (80.0) 
8 (100.0) 12 (92.3)  4 (100.0) 4 (100.0) 8 (100.0) 5 (100.0) 10 (100.0) 8 (100.0) 39 (100.0) 51 (98.1) 
Grade  2 
2 (40.0) 
6 (75.0) 
8 (61.5)  4 (100.0) 3 (75.0) 
7 (87.5) 
4 (80.0) 
9 (90.0) 
7 (87.5) 
34 (87.2) 42 (80.8) 
Grade  3 
1 (20.0) 
4 (50.0) 
5 (38.5)  4 (100.0) 3 (75.0) 
6 (75.0) 
1 (20.0) 
5 (50.0) 
5 (62.5) 
24 (61.5) 29 (55.8) 
Grade  4 
0 (0.0) 
1 (12.5) 
1 (7.7) 
 3 (75.0) 
2 (50.0) 
0 (0.0) 
1 (20.0) 
0 (0.0) 
1 (12.5) 
7 (17.9) 
8 (15.4) 
Serious adverse events 
0 (0.0) 
1 (12.5) 
1 (7.7) 
 1 (25.0) 
2 (50.0) 
2 (25.0) 
1 (20.0) 
1 (10.0) 
1 (12.5) 
8 (20.5) 
9 (17.3) 
Leading to discontinuation of 
investigational product 
0 (0.0) 
0 (0.0) 
0 (0.0) 
 1 (25.0) 
1 (25.0) 
2 (25.0) 
1 (20.0) 
0 (0.0) 
1 (12.5) 
6 (15.4) 
6 (11.5) 
Fatal adverse events 
0 (0.0) 
0 (0.0) 
0 (0.0) 
 0 (0.0) 
0 (0.0) 
0 (0.0) 
1 (20.0) 
0 (0.0) 
0 (0.0) 
1 (2.6) 
1 (1.9) 
Page 1 of 2 
Footnotes and abbreviations are on the last page of the table. 

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Part 2  Evaluation of 2 oprozomib formulations administered at different increasing 
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Product:  Oprozomib 
Protocol Number:  20160104 
Date:  27 January 2021 
Page 103 of 125 
CONFIDENTIAL 
 
 
17. 
APPENDICES 

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Product:  Oprozomib
Protocol Number:  20160104
Date:  13 December 2018
Page 1 of 8
CONFIDENTIAL
Amendment 4
Protocol Title:  A Phase 1b Study Evaluating the Safety, Tolerability, 
Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide 
and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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